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

NCT07100652 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-08-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jiangxi Maternal and Child Health Hospital

    collaborator OTHER

  • Jiulongpo No.1 People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100652 on ClinicalTrials.gov