Patent Ductus Arteriosus, Prematurity, Respiratory Distress Syndrome
Conditions
Keywords
Very Premature, RDS, Surfactant
Brief summary
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants \< 30 weeks gestational age at birth.
Detailed description
Specific Aims: * To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta * To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta * To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta * To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.
Interventions
DRUGSurvanta (beractant)
beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)
DRUGCurosurf (poractant)
poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)
Sponsors
Dey LP
Alan Fujii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Hours
Healthy volunteers
No
Inclusion criteria
* \<29 6/7 and \>24 0/7 weeks gestational age * Inborn at the participating institution enrolling the patient * FIO2 \>25% and Intubated with mean airway pressure \> 5 cm H20 * \<8 hours age at randomization * Signed informed consent from parent(s)
Exclusion criteria
* \<500 g birth weight * \<24 0/7 weeks gestational age (best estimate) * Prolonged Premature Rupture of membranes \>3 weeks (21 days) * Apgar score \< 3 at 5 minutes * Impending death anticipated within the first 3 days of life, moribund * Severe congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 48 hours after surfactant administration | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team. |
| Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration | 72 hours after surfactant administration | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team. |
| Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 48 hours after surfactant administration | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. |
| Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration. | 72 hours after surfactant administration | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 48 hours after surfactant administration | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. |
| Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 72 hours after surfactant administration | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. |
| Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant) | Hemodynamically significant PDA at > 2 days | Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA \> 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support. |
| Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | First hour after 2nd surfactant dose | Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures. |
| Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | One hour following second surfactant dose at 12-24 hours after initial dose | Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage. |
| Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) | 36 weeks post menstrual age | Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at \>/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome. |
| Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU. | NICU hospitalization, up to 42 weeks post menstrual age | Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other. |
Countries
United States
Participant flow
Recruitment details
Patients born between 1/2005 and 5/2008 with respiratory distress syndrome requiring mechanical ventilation, \<30 weeks gestation, greater than 500 g and whose parents provided informed consent were included in the study. Infants with multiple congenital anomalies, significant congenital heart disease were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals) | 27 |
| Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses) | 25 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 2 |
Baseline characteristics
| Characteristic | Beractant Arm | Poractant Alfa Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 25 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age in weeks | 26.7 weeks STANDARD_DEVIATION 1.7 | 27.1 weeks STANDARD_DEVIATION 1.6 | 26.9 weeks STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 20 Participants |
| Sex: Female, Male Male | 20 Participants | 12 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 27 | 8 / 25 |
| serious Total, serious adverse events | 19 / 27 | 9 / 25 |
Outcome results
Primary
Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.
Time frame: 72 hours after surfactant administration
Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beractant Arm | Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration | 7.9 cm H20 | Standard Error 0.6 |
| Poractant Alfa Arm | Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration | 6.0 cm H20 | Standard Error 0.7 |
Comparison: Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).p-value: <0.05t-test, 2 sided
Primary
Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.
Time frame: 48 hours after surfactant administration
Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beractant Arm | Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 8.6 cm H20 | Standard Error 0.8 |
| Poractant Alfa Arm | Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 6.4 cm H20 | Standard Error 0.4 |
Comparison: Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.p-value: <0.05t-test, 2 sided
Primary
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Time frame: 48 hours after surfactant administration
Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beractant Arm | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 274 cm H20-Percent of O2 | Standard Error 35 |
| Poractant Alfa Arm | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | 170 cm H20-Percent of O2 | Standard Error 18 |
Comparison: Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).p-value: <0.05t-test, 2 sided
Primary
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Time frame: 72 hours after surfactant administration
Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beractant Arm | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration. | 226 cm H20-Percent of O2 | Standard Error 29 |
| Poractant Alfa Arm | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration. | 140 cm H20-Percent of O2 | Standard Error 16 |
Comparison: Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).p-value: <0.05t-test, 2 sided
Secondary
Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.
Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.
Time frame: NICU hospitalization, up to 42 weeks post menstrual age
Population: All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at \> 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Beractant Arm | Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU. | 16 Subjects with BPD + Neonatal Deaths |
| Poractant Alfa Arm | Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU. | 10 Subjects with BPD + Neonatal Deaths |
p-value: >0.0590% CI: [0.84, 2.63]Mantel Haenszel
Secondary
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.
Time frame: One hour following second surfactant dose at 12-24 hours after initial dose
Population: The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Beractant Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Blood Flow Velocity, before surfactant (cm/sec) | 12.5 Percent change from baseline velocity | Standard Error 1.5 |
| Beractant Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Peak Blood Flow Velocity, post surfactant (cm/sec) | 18.3 Percent change from baseline velocity | Standard Error 2.4 |
| Beractant Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Peak Change in Blood Flow Velocity (cm/sec) | 5.6 Percent change from baseline velocity | Standard Error 1.3 |
| Beractant Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Percent Change in Blood Flow Velocity (%) | 47.4 Percent change from baseline velocity | Standard Error 11.9 |
| Poractant Alfa Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Percent Change in Blood Flow Velocity (%) | -1.8 Percent change from baseline velocity | Standard Error 14.6 |
| Poractant Alfa Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Blood Flow Velocity, before surfactant (cm/sec) | 22.4 Percent change from baseline velocity | Standard Error 2.8 |
| Poractant Alfa Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Peak Change in Blood Flow Velocity (cm/sec) | -2.0 Percent change from baseline velocity | Standard Error 3.1 |
| Poractant Alfa Arm | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Peak Blood Flow Velocity, post surfactant (cm/sec) | 20.4 Percent change from baseline velocity | Standard Error 2.1 |
p-value: <0.01t-test, 2 sided
Secondary
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)
Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.
Time frame: First hour after 2nd surfactant dose
Population: Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Beractant Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Baseline PDA Flow, before surfactant (cc/min) | 138 cc/min | Standard Error 36 |
| Beractant Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Maximal PDA Flow, following surfactant (cc/min) | 169 cc/min | Standard Error 52 |
| Beractant Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Change in PDA Flow, following surfactant (cc/min) | 32 cc/min | Standard Error 42 |
| Poractant Alfa Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Baseline PDA Flow, before surfactant (cc/min) | 123 cc/min | Standard Error 45 |
| Poractant Alfa Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Maximal PDA Flow, following surfactant (cc/min) | 143 cc/min | Standard Error 35 |
| Poractant Alfa Arm | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Change in PDA Flow, following surfactant (cc/min) | 20 cc/min | Standard Error 37 |
p-value: >0.05t-test, 2 sided
Secondary
Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)
Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA \> 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.
Time frame: Hemodynamically significant PDA at > 2 days
Population: Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at \>3 days, were tallied
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Beractant Arm | Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant) | 19 Subjects |
| Poractant Alfa Arm | Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant) | 8 Subjects |
p-value: <0.0195% CI: [1.29, 4.38]Mantel Haenszel
Secondary
Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Time frame: 48 hours after surfactant administration
Population: Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Beractant Arm | Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 6 Participants successfully extubated |
| Poractant Alfa Arm | Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 13 Participants successfully extubated |
p-value: <0.0595% CI: [0.19, 0.95]Mantel Haenszel
Secondary
Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Time frame: 72 hours after surfactant administration
Population: Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Beractant Arm | Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 8 Participants successfully extubated |
| Poractant Alfa Arm | Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | 15 Participants successfully extubated |
p-value: <0.0595% CI: [0.25, 0.96]Mantel Haenszel
Secondary
Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)
Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at \>/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.
Time frame: 36 weeks post menstrual age
Population: Population analyzed was limited to those subjects who survived to \>36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at \>36 weeks post menstrual age) were tallied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Beractant Arm | Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) | 11 Surviving Subjects with BPD |
| Poractant Alfa Arm | Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) | 8 Surviving Subjects with BPD |
p-value: >0.0595% CI: [0.71, 2.89]Mantel Haenszel