Bronchopulmonary Dysplasia, Infant, Newborn, Diseases, Infant, Small for Gestational Age, Other Preterm Infants, Premature Birth, Retinopathy of Prematurity
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Surfactant, Intubation, Neurodevelopmental impairment, Pulse oximetry, Oxygen saturation, Positive-Pressure Respiration
Brief summary
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.
Detailed description
Study subjects were infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by best obstetric estimate) were enrolled because more than 80% of such infants in the Network are intubated, usually early in their neonatal course. The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50% of such infants if they are not intubated for surfactant. We excluded infants of 23 weeks or less in view of their extremely high mortality and morbidity, and their almost universal need for delivery room intubation for resuscitation. Secondary studies included: neuroimaging/MRI, growth, and breathing outcomes. Strata: There were two randomization strata, infants of 24 0/7ths to 25 6/7ths weeks, and infants of 26 0/7ths-27 6/7ths weeks by best obstetrical estimate. Randomization: Randomization was stratified by gestational age group, occurred prior to delivery for consented deliveries, and was performed by utilizing specially prepared double-sealed envelopes. Deliveries were randomized as a unit, thus multiples, twins, triplets, etc. were randomized to the same arm of the trial. Informed Consent: Parents were approached prior to delivery for informed consent, and their infants enrolled at delivery. Study Intervention: Mode of Ventilatory Support The intervention began after birth when the infant was given to the resuscitation team. The conduct of the resuscitation followed usual guidelines, and once stabilized, all Control infants in both strata received prophylactic/early surfactant (within one hour of age), whereas all Treatment infants were placed on CPAP/PEEP following stabilization, and were intubated only for resuscitation indications. Pulse Oximeter Allocation: Infants were randomized to receive either a high- or low-saturation of peripheral oxygen (SpO2) as monitored by a study oximeter immediately following NICU admission, with a maximum allowable delay of two hours following admission. The SUPPORT Trial recruitment was temporarily paused on November 23, 2005 based on concern regarding pulse oximeter readings \> 95% and due to concern regarding separation of the two arms of the oximetry portion of the study. Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95%. Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values, which both showed group differences. The trial was restarted on February 6, 2006. Follow-up: Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment. Extended follow-up: Subjects enrolled in the Neuroimaging/MRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development. Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone (DHEA) to: (a) blood pressure and adiposity; (b) prenatal and postnatal growth; and (c) DNA methylation patterns.
Interventions
DRUGSurfactant
Intubation and administration of surfactant by 1 hour of age.
DEVICEContinuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
DRUGSupplemental oxygen with target saturation of 85 to 89%
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
DRUGSupplemental oxygen with target saturation of 91 to 95%
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 27 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate * Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation * Infants whose parents/legal guardians have provided consent for enrollment, or * Infants without known major congenital malformations
Exclusion criteria
* Any infant transported to the center after delivery * Infants whose parents/legal guardians refuse consent * Infants born during a time when the research apparatus/study personnel are not available * Infants \< 24 weeks 0 days or \> 28 weeks 0 days, completed weeks of gestation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | 55 weeks |
| Survival Without Bronchopulmonary Dysplasia (BPD) | 36 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | Entire NICU stay, up to 120 days | The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation. |
| Survival Without Ventilation | From birth through first 7 days of life. | Surviving the first 7 days of life without any need for ventilation by day 7 |
| Received Surfactant Treatment | From birth through 120 days of life. | Received any surfactant treatment. |
| Number of Participants With Air Leaks | From birth through first 14 days of life. | Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium. |
| Physiological Bronchopulmonary Dysplasia | 36 weeks post menstrual age. | Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (\<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen \<27% and had majority saturation \>90%, or they were receiving effective oxygen 27-30% and had majority saturation \>96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge. |
| Death | 18-22 months | Participants who died by their follow-up visit at 18-22 months. |
| Severe Intraventricular Hemorrhage (IVH) | From birth through first 120 days of life. | There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV. |
| Periventricular Leukomalacia (PVL) | From birth through first 120 days of life. | Increased echogenicity or cysts in periventricular region. |
| Endotracheal Intubation | Delivery Room, post-delivery | Insertion of a tube into the trachea to allow positive pressure ventilation for breathing. |
| Duration of Oxygen Supplementation | From birth through first 120 days of life. | The length of time in days that a participant had oxygen supplementation. |
| Pulse Oximetry Values > 90% | From birth through first 120 days of life. | Percentage of time spent above 90% oxygen saturation. |
| Blindness in at Least One Eye | 18-22 months | Blindness in at least one eye by 18-22 months of life. |
| Received Postnatal Steroids | From birth through first 120 days of life. | Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease. |
| Necrotizing Enterocolitis (NEC) | From birth through first 120 days of life. | Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC. |
| Cerebral Palsy | 18-22 months | Incidence of cerebral palsy. |
| Threshold Retinopathy of Prematurity (ROP) Requiring Surgery | From birth through first 120 days of life. | Diagnosis of retinopathy of prematurity which resulted in requiring surgery. |
| Death or Neurodevelopmental Impairment | 18-22 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apgar Scores at 5 Minutes | 5 minutes after birth. | Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth. |
Countries
United States
Participant flow
Recruitment details
3546 infants assessed for eligibility from 3127 pregnancies. 2230 were excluded for not meeting eligibility criteria or parental permission was not granted or other reasons.
Pre-assignment details
235 did not meet eligiblity criteria 125 did not have personnel or equipment available 699 were eligible did not have consent sought 344 were eligible but parent or guardian was not available 748 were eligible but parent or guardian denied permission to enroll 68 were eligible and had permission but were not randomized 11 had other reasons
Participants by arm
| Arm | Count |
|---|---|
| CPAP and Lower Range Oxygen Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%) | 336 |
| CPAP and Higher Range Oxygen Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%) | 327 |
| Early Surfactant and Lower Range Oxygen Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%) | 318 |
| Early Surfactant and Higher Range Oxygen Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%) | 335 |
| Total | 1,316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow up at 18-22 Months Corrected Age | Death | 5 | 7 | 5 | 4 |
| Follow up at 18-22 Months Corrected Age | Undetermined retinopathy status | 8 | 7 | 13 | 7 |
| Main Study | Death | 68 | 60 | 62 | 47 |
Baseline characteristics
| Characteristic | CPAP and Lower Range Oxygen | CPAP and Higher Range Oxygen | Early Surfactant and Lower Range Oxygen | Early Surfactant and Higher Range Oxygen | Total |
|---|---|---|---|---|---|
| Age, Customized >23 weeks and <28 weeks gestational age | 336 participants | 327 participants | 318 participants | 335 participants | 1316 participants |
| Region of Enrollment United States | 336 participants | 327 participants | 318 participants | 335 participants | 1316 participants |
| Sex: Female, Male Female | 172 Participants | 149 Participants | 141 Participants | 142 Participants | 604 Participants |
| Sex: Female, Male Male | 164 Participants | 178 Participants | 177 Participants | 193 Participants | 712 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 318 | 5 / 335 | 11 / 336 | 7 / 327 |
| serious Total, serious adverse events | 204 / 318 | 227 / 335 | 231 / 336 | 224 / 327 |
Outcome results
Primary
Survival Without Bronchopulmonary Dysplasia (BPD)
Time frame: 36 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP | Survival Without Bronchopulmonary Dysplasia (BPD) | 346 Participants |
| Surfactant | Survival Without Bronchopulmonary Dysplasia (BPD) | 320 Participants |
Primary
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
Time frame: 55 weeks
Population: 49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP | Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | 434 participants |
| Surfactant | Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | 418 participants |
Secondary
Blindness in at Least One Eye
Blindness in at least one eye by 18-22 months of life.
Time frame: 18-22 months
Population: 990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Blindness in at Least One Eye | 4 Participants |
| Surfactant | Blindness in at Least One Eye | 3 Participants |
| Lower Oxygen Saturation Target | Blindness in at Least One Eye | 1 Participants |
| Higher Oxygen Saturation Target | Blindness in at Least One Eye | 5 Participants |
Secondary
Cerebral Palsy
Incidence of cerebral palsy.
Time frame: 18-22 months
Population: 990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Cerebral Palsy | 17 Participants |
| Surfactant | Cerebral Palsy | 17 Participants |
| Lower Oxygen Saturation Target | Cerebral Palsy | 26 Participants |
| Higher Oxygen Saturation Target | Cerebral Palsy | 24 Participants |
Secondary
Death
Participants who died by their follow-up visit at 18-22 months.
Time frame: 18-22 months
Population: 1281 participants with confirmed deaths or survivals by follow-up. 35 were excluded due to incomplete follow-up visits: 21 in low oxygen group, 14 in high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Death | 73 Participants |
| Surfactant | Death | 67 Participants |
| Lower Oxygen Saturation Target | Death | 67 Participants |
| Higher Oxygen Saturation Target | Death | 51 Participants |
Secondary
Death or Neurodevelopmental Impairment
Time frame: 18-22 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP | Death or Neurodevelopmental Impairment | 173 participants |
| Surfactant | Death or Neurodevelopmental Impairment | 183 participants |
| Lower Oxygen Saturation Target | Death or Neurodevelopmental Impairment | 185 participants |
| Higher Oxygen Saturation Target | Death or Neurodevelopmental Impairment | 171 participants |
Secondary
Duration of Mechanical Ventilation
The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.
Time frame: Entire NICU stay, up to 120 days
Population: 1078 participants survived to discharge and they all had information available for regarding use of mechanical ventilation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Duration of Mechanical Ventilation | 11 days |
| Surfactant | Duration of Mechanical Ventilation | 13 days |
| Lower Oxygen Saturation Target | Duration of Mechanical Ventilation | 7 days |
| Higher Oxygen Saturation Target | Duration of Mechanical Ventilation | 11.5 days |
Secondary
Duration of Oxygen Supplementation
The length of time in days that a participant had oxygen supplementation.
Time frame: From birth through first 120 days of life.
Population: 1078 participants survived to discharge and they all had information available regarding the duration of their oxygen supplementation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Duration of Oxygen Supplementation | 46 days |
| Surfactant | Duration of Oxygen Supplementation | 60 days |
| Lower Oxygen Saturation Target | Duration of Oxygen Supplementation | 43 days |
| Higher Oxygen Saturation Target | Duration of Oxygen Supplementation | 59 days |
Secondary
Endotracheal Intubation
Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
Time frame: Delivery Room, post-delivery
Population: 1312 participants had non-missing data on whether they experienced endotracheal intubation. 4 participants were excluded due to missing information: 2 infants in the low oxygen group, 2 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Endotracheal Intubation | 294 Participants |
| Surfactant | Endotracheal Intubation | 315 Participants |
| Lower Oxygen Saturation Target | Endotracheal Intubation | 110 Participants |
| Higher Oxygen Saturation Target | Endotracheal Intubation | 117 Participants |
Secondary
Necrotizing Enterocolitis (NEC)
Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.
Time frame: From birth through first 120 days of life.
Population: 1290 participants had known NEC statuses. 26 were excluded due to missing NEC data: 13 infants in the low oxygen group, 13 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Necrotizing Enterocolitis (NEC) | 36 Participants |
| Surfactant | Necrotizing Enterocolitis (NEC) | 27 Participants |
| Lower Oxygen Saturation Target | Necrotizing Enterocolitis (NEC) | 40 Participants |
| Higher Oxygen Saturation Target | Necrotizing Enterocolitis (NEC) | 43 Participants |
Secondary
Number of Participants With Air Leaks
Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.
Time frame: From birth through first 14 days of life.
Population: All 1316 participants had data on incidence of air leaks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Number of Participants With Air Leaks | 26 Participants |
| Surfactant | Number of Participants With Air Leaks | 22 Participants |
| Lower Oxygen Saturation Target | Number of Participants With Air Leaks | 25 Participants |
| Higher Oxygen Saturation Target | Number of Participants With Air Leaks | 20 Participants |
Secondary
Periventricular Leukomalacia (PVL)
Increased echogenicity or cysts in periventricular region.
Time frame: From birth through first 120 days of life.
Population: 1272 participants had known PVL statuses. 44 were excluded due to unknown PVL status: 23 infants in the low oxygen group, 21 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Periventricular Leukomalacia (PVL) | 10 Participants |
| Surfactant | Periventricular Leukomalacia (PVL) | 16 Participants |
| Lower Oxygen Saturation Target | Periventricular Leukomalacia (PVL) | 14 Participants |
| Higher Oxygen Saturation Target | Periventricular Leukomalacia (PVL) | 14 Participants |
Secondary
Physiological Bronchopulmonary Dysplasia
Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (\<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen \<27% and had majority saturation \>90%, or they were receiving effective oxygen 27-30% and had majority saturation \>96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.
Time frame: 36 weeks post menstrual age.
Population: 1108 participants survived to 36 weeks and had BPD information. 208 participants did not survive to 36 weeks and were excluded: 114 from the low oxygen group, 94 from the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Physiological Bronchopulmonary Dysplasia | 102 Participants |
| Surfactant | Physiological Bronchopulmonary Dysplasia | 117 Participants |
| Lower Oxygen Saturation Target | Physiological Bronchopulmonary Dysplasia | 103 Participants |
| Higher Oxygen Saturation Target | Physiological Bronchopulmonary Dysplasia | 120 Participants |
Secondary
Pulse Oximetry Values > 90%
Percentage of time spent above 90% oxygen saturation.
Time frame: From birth through first 120 days of life.
Population: 90 were excluded due to incomplete data: 48 from the low oxygen saturation group and 42 from the high oxygen saturation group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Pulse Oximetry Values > 90% | 62 percentage of time |
| Surfactant | Pulse Oximetry Values > 90% | 76 percentage of time |
| Lower Oxygen Saturation Target | Pulse Oximetry Values > 90% | 63 percentage of time |
| Higher Oxygen Saturation Target | Pulse Oximetry Values > 90% | 77 percentage of time |
Secondary
Received Postnatal Steroids
Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.
Time frame: From birth through first 120 days of life.
Population: 1280 participants had information regarding whether they received postnatal steroids. 36 participants were excluded due to missing data: 18 infants in the low oxygen group, 18 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Received Postnatal Steroids | 42 Participants |
| Surfactant | Received Postnatal Steroids | 41 Participants |
| Lower Oxygen Saturation Target | Received Postnatal Steroids | 19 Participants |
| Higher Oxygen Saturation Target | Received Postnatal Steroids | 28 Participants |
Secondary
Received Surfactant Treatment
Received any surfactant treatment.
Time frame: From birth through 120 days of life.
Population: 1312 participants had known surfactant treatment. 4 were excluded due to unknown surfactant treatment: 2 infants in the low oxygen group, 2 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Received Surfactant Treatment | 159 Participants |
| Surfactant | Received Surfactant Treatment | 176 Participants |
| Lower Oxygen Saturation Target | Received Surfactant Treatment | 42 Participants |
| Higher Oxygen Saturation Target | Received Surfactant Treatment | 51 Participants |
Secondary
Severe Intraventricular Hemorrhage (IVH)
There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.
Time frame: From birth through first 120 days of life.
Population: 1270 participants had known IVH grades. 46 were excluded due to unknown IVH status: 24 infants from the low oxygen group, 22 infants from high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Severe Intraventricular Hemorrhage (IVH) | 34 Participants |
| Surfactant | Severe Intraventricular Hemorrhage (IVH) | 38 Participants |
| Lower Oxygen Saturation Target | Severe Intraventricular Hemorrhage (IVH) | 49 Participants |
| Higher Oxygen Saturation Target | Severe Intraventricular Hemorrhage (IVH) | 43 Participants |
Secondary
Survival Without Ventilation
Surviving the first 7 days of life without any need for ventilation by day 7
Time frame: From birth through first 7 days of life.
Population: 1307 participants had known survival and ventilation statuses. 9 participants were excluded due to unknown ventilation status from birth through 7 days of life: 6 infants in the lower oxygen group, 3 infants in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Survival Without Ventilation | 161 Participants |
| Surfactant | Survival Without Ventilation | 157 Participants |
| Lower Oxygen Saturation Target | Survival Without Ventilation | 190 Participants |
| Higher Oxygen Saturation Target | Survival Without Ventilation | 172 Participants |
Secondary
Threshold Retinopathy of Prematurity (ROP) Requiring Surgery
Diagnosis of retinopathy of prematurity which resulted in requiring surgery.
Time frame: From birth through first 120 days of life.
Population: 997 surviving participants with ROP data were included. 319 total participants were excluded due to death (N=224) or missing ROP data (N=95): 171 in the low oxygen group, 148 in the high oxygen group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Threshold Retinopathy of Prematurity (ROP) Requiring Surgery | 19 Participants |
| Surfactant | Threshold Retinopathy of Prematurity (ROP) Requiring Surgery | 44 Participants |
| Lower Oxygen Saturation Target | Threshold Retinopathy of Prematurity (ROP) Requiring Surgery | 17 Participants |
| Higher Oxygen Saturation Target | Threshold Retinopathy of Prematurity (ROP) Requiring Surgery | 47 Participants |
Other Pre-specified
Apgar Scores at 5 Minutes
Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth.
Time frame: 5 minutes after birth.
Population: All 1316 participants had APGAR scores at 5 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Apgar Scores at 5 Minutes | 7 scores on a scale |
| Surfactant | Apgar Scores at 5 Minutes | 7 scores on a scale |
| Lower Oxygen Saturation Target | Apgar Scores at 5 Minutes | 7 scores on a scale |
| Higher Oxygen Saturation Target | Apgar Scores at 5 Minutes | 7 scores on a scale |