Phase 3
N=1,316
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Infant, Newborn, Diseases · Other Preterm Infants · Infant, Small for Gestational Age · Premature Birth · Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT00233324 ↗Enrolled (actual)
1,316
Serious AEs
67.3%
Results posted
Dec 2014
Primary outcome: Primary: Survival Without Bronchopulmonary Dysplasia (BPD) — 346; 320 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Surfactant (Drug); Continuous Positive Airway Pressure (CPAP) (Device); Supplemental oxygen with target saturation of 85 to 89% (Drug); Supplemental oxygen with target saturation of 91 to 95% (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Without Bronchopulmonary Dysplasia (BPD) |
346; 320 | — |
| PRIMARY Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) |
434; 418 | — |
| SECONDARY Death or Neurodevelopmental Impairment |
173; 183; 185; 171 | — |
| SECONDARY Duration of Mechanical Ventilation |
11; 13; 7; 11.5 | — |
| SECONDARY Survival Without Ventilation |
161; 157; 190; 172 | — |
| SECONDARY Received Surfactant Treatment |
159; 176; 42; 51 | — |
| SECONDARY Number of Participants With Air Leaks |
26; 22; 25; 20 | — |
| SECONDARY Physiological Bronchopulmonary Dysplasia |
102; 117; 103; 120 | — |
| SECONDARY Death |
73; 67; 67; 51 | — |
| SECONDARY Severe Intraventricular Hemorrhage (IVH) |
34; 38; 49; 43 | — |
| SECONDARY Periventricular Leukomalacia (PVL) |
10; 16; 14; 14 | — |
| SECONDARY Threshold Retinopathy of Prematurity (ROP) Requiring Surgery |
19; 44; 17; 47 | — |
| SECONDARY Endotracheal Intubation |
294; 315; 110; 117 | — |
| SECONDARY Duration of Oxygen Supplementation |
46; 60; 43; 59 | — |
| SECONDARY Pulse Oximetry Values > 90% |
62; 76; 63; 77 | — |
| SECONDARY Blindness in at Least One Eye |
4; 3; 1; 5 | — |
| SECONDARY Received Postnatal Steroids |
42; 41; 19; 28 | — |
| SECONDARY Necrotizing Enterocolitis (NEC) |
36; 27; 40; 43 | — |
| SECONDARY Cerebral Palsy |
17; 17; 26; 24 | — |
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.
Eligibility Criteria
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 28 weeks 0 days, completed weeks of gestation
Data sourced from ClinicalTrials.gov (NCT00233324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.