Phase 3
N=648
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Bottom Line
View on ClinicalTrials.gov: NCT00244101 ↗Enrolled (actual)
648
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Death or Chronic Lung Disease — 76; 68; 62 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PS Group (Drug); NCPAP Group (Device); ISX Group (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vermont Oxford Network
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death or Chronic Lung Disease |
76; 68; 62 | — |
| PRIMARY Death |
15; 9; 15 | — |
Summary
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.
Eligibility Criteria
Inclusion Criteria
Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:
- Imminent delivery
- No potentially life-threatening congenital anomaly or genetic syndrome
- No known lung maturity
- Antenatal steroid status known
- Written, informed consent obtained (on admission or prior to delivery).
Exclusion Criteria
- Stillborn (Apgar score of 0 at one minute of age)
- Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
Data sourced from ClinicalTrials.gov (NCT00244101). 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.