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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07100652
Lead Sponsor Jiulongpo No.1 People's Hospital
Collaborators: Jiangxi Maternal and Child Health Hospital
Conditions
(from sponsor)		 Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Related terms Hyaline Membrane Disease, Respiratory Distress Syndrome
Enrollment 384 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov