At a glance
ClinicalIndex Comparison Record- ✓Gestational age 26+0 to 29+6 weeks
- ✓Imminent delivery
- ✓Antenatal steroid status known
- ✓No known lung maturity
- ✕Potentially life-threatening congenital anomaly or genetic syndrome
- ✕Stillborn or Apgar score of 0 at one minute
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
In Brief
A Phase 3 clinical trial evaluating PS Group, NCPAP Group, and 1 other intervention for Respiratory Distress Syndrome, Newborn. Completed, enrolled 648 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.