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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
Sponsor: Xu Falin
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.
Key Details
Gender
All
Age Range
26 Weeks - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-09-04
Completion Date
2026-06-30
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The Third Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, China