NCT07100652

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

Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Jiulongpo No.1 People's Hospital · Academic / Other
• Sex: All
• Age: 3 Hours
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])

Interventions

Type	Name	Description
PROCEDURE	Threshold FiO₂	Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) \>0.25. Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to \>0.3 based on the infant's clinical condition.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: China