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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

NCT07235345 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Neonatal Respiratory Distress Syndrome

Interventions

OTHER

According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold

According to the relevant clinical guidelines or expert consensus, the pressure, respiratory rate and other parameters were set. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children. To maintain SpO2 90%-94%. According to the FiO2 threshold corresponding to randomization, PS treatment was given when FiO2 reached the threshold (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be repeated if necessary if the disease progressed). PS treatment was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used.

Sponsors & Collaborators

  • Zhumadian Central Hospital

    collaborator OTHER

  • Zhengzhou Central Hospital

    collaborator OTHER

  • Xinyang Central Hospital

    collaborator OTHER

  • Xinxiang Central Hospital

    collaborator OTHER

  • Nanyang Central Hospital

    collaborator OTHER

  • Zhoukou Central Hospital

    collaborator OTHER

  • Xu Falin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2026-06-30
Completion
2026-06-30

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 NCT07235345 on ClinicalTrials.gov