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Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
Sponsor: Jiulongpo No.1 People's Hospital
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.
Official title: Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT
Key Details
Gender
All
Age Range
Any - 3 Hours
Study Type
INTERVENTIONAL
Enrollment
384
Start Date
2026-01-01
Completion Date
2027-02-01
Last Updated
2025-08-03
Healthy Volunteers
No
Interventions
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.
Locations (1)
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China