Necrotizing Enterocolitis
Conditions
Brief summary
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
Detailed description
Protocol STP206-002 is designed as a multi-center, randomized, double-blind, placebo controlled dose escalation study of the safety and tolerability of two doses of STP206 versus control in four sequentially decreasing birth weight strata. The primary objective of this study is to assess the safety and tolerability of once daily dosing of two dose levels of STP206 versus control in four different birth weight strata in premature neonates. Secondary objectives of this study include assessment of fecal shedding of STP206 throughout dosing and describing the incidence of NEC, incidence of relevant clinical events (sepsis/bacteremia, feeding intolerance, morbidity/complications of prematurity) and neonatal growth progression in the STP206 and control treatment groups. Neonates for whom informed consent is obtained and who meet eligibility criteria will be eligible to enroll in this study. All neonates enrolled will receive daily doses of blinded study treatment for between 2 and 11 weeks with the duration of dosing based upon gestational age at birth. All neonates enrolled in the study will be placed under Universal Precautions and all study personnel with subject contact are trained in appropriate neonatal intensive care unit (NICU) infection control practices. While in the NICU, neonates will be evaluated daily for signs/symptoms of NEC, feeding volumes/feeding tolerance, adverse events, and concomitant medications. Physical examinations and vital signs will be performed daily during the dosing period and at the end of dosing/NICU discharge. Growth assessments will be performed every other week while in the NICU and at the end of dosing/NICU discharge. Assessments for complications of prematurity, including retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), and bronchopulmonary dysplasia (BPD) will be performed at protocol defined timeframes. Neonates enrolled in the study will have fecal/meconium samples collected daily through 4 days following the start of dosing and weekly thereafter until NICU discharge to determine fecal shedding of STP6 and STP11. Following completion of blinded study treatment dosing, neonates will be evaluated at 1 week, 4 weeks, 3 months, and 6 months for safety and growth assessments. Neonates will be stratified into the following four birth weights: 2000-1501g, 1500 to 1000 g, 999 to 750 g and 749 to 500 g. Each birth weight stratum will contain 2 dosing groups - a low dose STP206 group and a high dose STP206 group. Within each birth weight strata/dose level, subjects will be randomized in a 2:1 ratio to the STP206 or control group. Enrollment of neonates into study groups will occur sequentially. Enrollment into the high dose group within a birth weight stratum will not proceed until after the safety data from the low dose group is reviewed by the study independent Data Safety Monitoring Committee (DSMC). Similarly, enrollment into the next lower birth weight stratum will not proceed until the safety data from the high dose group of the prior weight stratum is reviewed by the study independent Data Safety Monitoring Committee (DSMC).
Interventions
BIOLOGICALSTP206
Live Biotherapeutic
OTHERControl
Sterile Water
Sponsors
Leadiant Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Days
Healthy volunteers
No
Inclusion criteria
1. Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B 2. Ability to start treatment within four days after birth. 3. Gestational age between 23 and 32 weeks at birth 4. Obtaining of informed consent from the subject's mother after full understanding of the study purpose and procedures. 5. Parents who agree to allow the Principal Investigator and his/her staff to follow the procedures and assessments required by the protocol
Exclusion criteria
1. Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days) 2. Infants with persistent pulmonary hypertension of the newborn (PPHN) 3. Congenital or chromosomal anomalies 4. Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is) 5. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care) 6. Other conditions of the infant which, in the opinion of the attending neonatologist, preclude participation 7. Positive maternal HIV status 8. Participation in another interventional clinical trial For Part A of the study, the following additional exclusion criterion will apply: 9. Small for gestational age neonates, i.e. neonates that weigh less that the 10th percentile for their gestational age according to the Estimated Fetal Weight Percentile Chart
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | 30 days after the last dose of blinded study treatment | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups |
| Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | 30 days after the last dose of blinded study treatment | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups |
| Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | 30 days after last administration of study drug | Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug |
| Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | 30 days after last administration of study drug | Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug |
| Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | 30 days after last administration of study drug | Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug |
| Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | 30 days after last administration of study drug | Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug |
| Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | 30 days after last administration of study drug | Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug |
| Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | 30 days after last administration of study drug | Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug |
| Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hospital discharge, up to 781 days | Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. |
| Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hospital discharge, up to 781 days | AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | From 5 days to 28 days | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. |
| Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | From 5 days to 28 days | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. |
| Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Start of dosing to 6 months | Mild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. |
| Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | Start of dosing to 6 months | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). |
| Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days | The presence of STP6 and STP11 was assessed in fecal cultures. |
| Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days | The presence of STP6 and STP11 was assessed in fecal cultures. |
| Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Start of dosing to 6 months | Mild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. |
| Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | Start of dosing to 6 months | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). |
| Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | Start of dosing to 6 months | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). |
| Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | Start of dosing to 6 months | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). |
| Number of Patients With Sepsis in Low-Dose Treatment Groups | Start of dosing to 6 months | The presence of STP6 and STP11 was assessed in peripheral blood cultures. |
| Number of Patients With Sepsis in High-Dose Treatment Groups | Start of dosing to 6 months | The presence of STP6 and STP11 was assessed in peripheral blood cultures. |
| Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | Start of dosing to 6 months | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. |
| Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | Start of dosing to 6 months | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. |
| Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Start of dosing to 6 months | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. |
| Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Start of dosing to 6 months | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose STP206 Biological
STP206: Live Biotherapeutic
\
1 billion (1 × 10\^9) cfu of STP6 and \
100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu) | 36 |
| High Dose STP206 Biological
STP206: Live Biotherapeutic
\
9 billion (9×10\^9) cfu of STP6 and \
900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu) | 33 |
| Control Sterile water | 34 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | All other reasons | 2 | 2 | 7 |
| Overall Study | Death | 2 | 1 | 1 |
| Overall Study | Enteral intake stopped >7 days | 0 | 1 | 1 |
| Overall Study | Necrotizing enterocolitis | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Low Dose STP206 | Total | Control | High Dose STP206 |
|---|---|---|---|---|
| 1-minute Apgar Score | 5.1 units on a scale STANDARD_DEVIATION 2.62 | 4.9 units on a scale STANDARD_DEVIATION 2.44 | 4.6 units on a scale STANDARD_DEVIATION 2.68 | 5.0 units on a scale STANDARD_DEVIATION 2.04 |
| 5-minute Apgar Score | 7.1 units on a scale STANDARD_DEVIATION 1.95 | 7.1 units on a scale STANDARD_DEVIATION 1.93 | 6.9 units on a scale STANDARD_DEVIATION 2.18 | 7.5 units on a scale STANDARD_DEVIATION 1.67 |
| Age, Customized <=28 | 24 Participants | 63 Participants | 23 Participants | 16 Participants |
| Age, Customized >28 | 12 Participants | 38 Participants | 10 Participants | 16 Participants |
| Birth Weight | 1110.8 grams STANDARD_DEVIATION 422.37 | 1120.8 grams STANDARD_DEVIATION 415.69 | 1141.0 grams STANDARD_DEVIATION 434.12 | 1110.8 grams STANDARD_DEVIATION 408.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 28 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 69 Participants | 23 Participants | 23 Participants |
| Sex: Female, Male Female | 12 Participants | 38 Participants | 14 Participants | 12 Participants |
| Sex: Female, Male Male | 24 Participants | 65 Participants | 20 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 1 / 4 | 1 / 9 | 0 / 4 | 0 / 9 | 0 / 5 | 2 / 8 | 0 / 4 | 0 / 8 | 0 / 4 | 0 / 8 | 0 / 4 | 0 / 8 | 0 / 4 | 1 / 8 | 1 / 4 |
| other Total, other adverse events | 7 / 8 | 4 / 4 | 7 / 9 | 3 / 4 | 9 / 9 | 5 / 5 | 8 / 8 | 4 / 4 | 6 / 8 | 4 / 4 | 7 / 8 | 3 / 4 | 7 / 8 | 3 / 4 | 8 / 8 | 4 / 4 |
| serious Total, serious adverse events | 1 / 8 | 1 / 4 | 2 / 9 | 2 / 4 | 3 / 9 | 3 / 5 | 5 / 8 | 1 / 4 | 1 / 8 | 0 / 4 | 2 / 8 | 0 / 4 | 2 / 8 | 1 / 4 | 4 / 8 | 4 / 4 |
Outcome results
Primary
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 1 Participants |
Primary
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 1 Participants |
Primary
Growth Assessment Classification in High-Dose Treatment Groups
AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Time frame: End of dosing/hospital discharge, up to 781 days
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 8 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 7 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 8 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 5 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 4 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 4 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 4 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 4 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 6 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 1 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 3 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 4 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 4 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 4 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 1 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 2 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 1 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 1 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 4 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 4 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 7 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 8 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 4 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 4 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 4 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 4 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 1 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 7 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 1 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 4 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 5 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 3 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 1 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : AGA | 3 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : LGA | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | End of dosing/hx discharge : AGA | 1 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : Number reporting | 3 participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in High-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 participants |
Primary
Growth Assessment Classification in Low-Dose Treatment Groups
Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Time frame: End of dosing/hospital discharge, up to 781 days
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 8 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 7 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 6 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 7 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 4 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 4 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 7 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 9 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 5 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 9 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 4 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 4 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 9 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 8 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 6 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 9 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 5 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 6 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 6 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 6 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : LGA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : LGA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : AGA | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Head-Spared | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : Number reporting | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Head-Spared | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : SGA/Symmetric | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | Baseline : SGA/Symmetric | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : AGA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Growth Assessment Classification in Low-Dose Treatment Groups | End of dosing/hx discharge : Number reporting | 3 Participants |
Primary
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Time frame: 30 days after the last dose of blinded study treatment
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 5 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 4 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 7 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 7 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 8 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Number of deaths | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one serious adverse event | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-emergent AE | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
Primary
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Time frame: 30 days after the last dose of blinded study treatment
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 7 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 4 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 7 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 9 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 8 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Number of deaths | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one related TEAE Grade 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one serious adverse event | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-emergent AE | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one TEAE Grade 3 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with TEAEs leading to stopping study drug | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | Subjects with at least one treatment-related TEAE | 0 Participants |
Primary
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricular tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
Primary
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
Primary
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Wheezing | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Adrenal insufficiency | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoglycaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Anaemia neonatal | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Enteral feeding intolerance | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Flatulence | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperkalaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Endocrine: Diabetes insipidus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Respiratory syncytial virus infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Vascular: Hypotension | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypochloraemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Conjunctivitis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin disorder | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Hydronephrosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage neona | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Cholestasis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Umbilical hernia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Osteopenia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Retinopathy of prematurity | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Late metabolic acidosis of newborn | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apparent life threatening event | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Vitamin D deficiency | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Stridor | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Rash | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Ophthalmia neonatorum | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypercalcaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Supraventricuar tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Pulmonary valve stenosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Fungal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Necrotising colitis | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Skin: Dermatitis diaper | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Cardiac: Tachycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Eye infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Blood sodium decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Dacryocystitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Apnoea neonatal | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Leukocytosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Intestinal stenosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hyperlipidaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Investigations: Haemoglobin decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Pulmonary interstitial emphysema synd | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Adrenogenital syndrome | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Coagulopathy | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: CNS ventriculitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Congenital: Laryngomalacia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Pneumonia klebsiella | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Renal: Renal failure acute | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Blood: Thrombocytopenia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
Primary
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Time frame: 30 days after last administration of study drug
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 3 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 5 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Reproductive: Testicular mass | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Constipation | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Oliguria | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Staphylococcal sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin discolouration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising colitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Diarrhoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Ankyloglossia congenital | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Renal failure | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Renal: Haematuria | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia klebsiella | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Skin disorder | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Endocarditis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Injury: Rib fracture | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Neonatal disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Haematochezia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Perinatal conditions: Jaundice neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Inguinal hernia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Nasopharyngitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Blister | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Cardio-respiratory arrest neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Convulsion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GI perforation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Nervous system: Intraventricular haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Cardiac murmur | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Feeding disorder neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Erythema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Neoplasms: Haemangioma | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Bradycardia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Ileus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Bone disorder | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Anaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Urinary tract infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Vascular: Venous insufficiency | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Chest X-ray abnormal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Necrotising enterocolitis neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Musculoskeletal: Osteopenia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Acidosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Escherichia sepsis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic alkalosis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Upper respiratory tract infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia staphylococcal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Cardiac: Foetal heart rate deceleration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Hypothermia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypernatraemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Platelet count decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Neonatal pneumonia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Body temperature decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Generalised oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Glucose tolerance impaired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Bacterial disease carrier | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Sepsis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Infusion site extravasation | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypokalaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypoalbuminemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Urine output decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Candida infection | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperglycaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | General: Oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hypocalcaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Hyperbilirubinaemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperkalaemia | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Haematocrit | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood glucose decreased | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Acinetobacter infection | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Acute respiratory distress syndrome | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypopituitarism | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Endocrine: Hypothyroidism | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Metabolic acidosis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary haemorrhage | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Rhinorrhoea | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Conjunctivitis | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Hepatobiliary: Cholestasis | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchospasm | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal respiratory distress syndrom | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Dacryostenosis acquired | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Cryptorchism | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyponatraemia | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Neonatal hypoxia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Eye: Discharge | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Blood: Thrombocytopenia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Pulmonary oedema | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Metabolism: Hyperphosphataemia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Bronchopulmonary dysplasia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood alkaline phosphatase incr | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Lab test abnormal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Aspiration | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: GERD | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity decreased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Respiratory disorder | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Patent ductus arteriosus | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Investigations: Blood osmolarity increased | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Vomiting | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Nasal congestion | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | GI: Abdominal distension | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Infections: Pneumonia escherichia | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Skin: Dermatitis diaper | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Respiratory: Apnoea neonatal | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Congenital: Atrial septal defect | 1 Participants |
Secondary
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Mild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Time frame: Start of dosing to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Any | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Severe | 0 Participants |
Secondary
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Mild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Time frame: Start of dosing to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 5 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 6 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Any | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Severe | 1 Participants |
Secondary
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIA | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | IIA | 0 Participants |
Secondary
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIIB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | IIA | 0 Participants |
Secondary
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in fecal cultures.
Time frame: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 8 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 3 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 8 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 2 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 3 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 5 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 1 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 5 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 5 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 6 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 6 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 4 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 5 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 5 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 5 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 0 participants |
Secondary
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in fecal cultures.
Time frame: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 8 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 6 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 4 participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 1 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 2 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 2 participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 1 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 6 participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 7 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 2 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 1 participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 3 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 2 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 6 participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 5 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 1 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 1 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 2 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 3 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 3 participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 3 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-6 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-11 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | End of dosing/hx discharge : STP-11 | 0 participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | Prior to Week 1 Day 4 : STP-6 | 0 participants |
Secondary
Number of Patients With Feeding Intolerance in High-Dose Treatment Groups
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | 3 Participants |
Secondary
Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 6 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 8 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | 2 Participants |
Secondary
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Time frame: From 5 days to 28 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 6 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade III | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Any | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade II | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | Grade I | 1 Participants |
Secondary
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Time frame: From 5 days to 28 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 4 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 6 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade IV | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade III | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Any | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade II | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | Grade I | 0 Participants |
Secondary
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Time frame: Start of dosing to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 3 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 2 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Any | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | Zone 3 | 0 Participants |
Secondary
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 7 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 2 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 3 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 1 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 4 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 0 | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 3 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 2 | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 5 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Any | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Stage 2 | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 1 | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | Zone 3 | 1 Participants |
Secondary
Number of Patients With Sepsis in High-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 8 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 4 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 7 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 4 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 6 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Present | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Absent | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in High-Dose Treatment Groups | Not evaluated | 0 Participants |
Secondary
Number of Patients With Sepsis in Low-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 6 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 2 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 1 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 2 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 7 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 3 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 7 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 4 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 5 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 3 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Present | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Absent | 4 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Sepsis in Low-Dose Treatment Groups | Not evaluated | 0 Participants |
Secondary
Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 1 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IA | 2 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | IB | 0 Participants |
Secondary
Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Time frame: Start of dosing to 6 months
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 1 Participants |
| Group 1a (Birth wt: 2000-1501 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 1a (Birth wt: 2000-1501 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 2a (Birth wt: 1500-1000 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 3a (Birth wt: 999-750 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Low Dose | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 1 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IA | 0 Participants |
| Group 4a (Birth wt: 749-500 g) Control | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | IB | 0 Participants |