Clinical Trial

To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation

Enrolling by Invitation
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Record status
This record was last updated November 19, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of \<32 weeks were enrolled. All infants received routine treatment after birth and were randomly divided into two groups according to the FiO2 threshold of PS under noninvasive assisted ventilation: Control group (FiO2=0.30) and low concentration group (FiO2=0.25). Clinical data were collected to explore the differences in clinical outcomes between the two groups.
Trial Details
NCT Number NCT07235345
Lead Sponsor Xu Falin
Collaborators: Zhumadian Central Hospital, Zhengzhou Central Hospital, Xinyang Central Hospital, Xinxiang Central Hospital, Nanyang Central Hospital, Zhoukou Central Hospital
Conditions Neonatal Respiratory Distress Syndrome
Enrollment 500 participants
Start Date 2025-09-04
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-19