Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants

This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ \>0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ \>0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.

NCT Number	NCT07100652
Lead Sponsor	Jiulongpo No.1 People's Hospital Collaborators: Jiangxi Maternal and Child Health Hospital
Conditions	Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Enrollment	384 participants
Start Date	2026-01-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-03