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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neonatal Respiratory Distress Syndrome
• Intervention / Treatment: Other: According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold

Detailed Description

① All the very/extremely preterm infants who met the criteria were divided into low concentration group and high concentration group according to the random number table method. The pressure, respiratory rate and other parameters were set according to the relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. 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.

② The basic information and perinatal outcomes of the two groups were collected; Outcome indicators: the main outcome indicators were the failure rate of non-invasive treatment, the time of tracheal intubation mechanical ventilation, the time of non-invasive assisted ventilation, the days of oxygen therapy, the time of the first use of PS, and the rate of repeated PS. The secondary outcomes included mortality, incidence of BPD, incidence of ROP, oxygen demand at 28 days after birth and 36 weeks of corrected gestational age, oxygen demand at discharge, length of hospital stay, and cost of hospitalization.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhengzhou
    • Henan, Zhengzhou, China, 455000
      • The Third Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Very preterm infants with gestational age <32 weeks
• immediately transferred to the neonatal intensive care unit
• signs of respiratory distress or RDS requiring respiratory support;
• Informed consent was obtained from the families of the children.

Exclusion Criteria:

• Giving up treatment or being transferred to other hospitals during hospitalization;
• requiring mechanical ventilation with tracheal intubation immediately or within 2 hours after birth
• complicated with pneumothorax, complex congenital heart disease, congenital malformation, congenital cystic lung disease, chromosomal inherited metabolic diseases, etc
• Incomplete clinical data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: High fraction of inspired oxygen; Parameters such as pressure and respiratory rate were set according to relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O, and FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children to maintain SpO2 90%-94%. When FiO2 reached 30%, PS treatment was given (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 should be given as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used.
Experimental: Low fraction of inspired oxygen; Parameters such as pressure and respiratory rate were set according to relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O, and FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children to maintain SpO2 90%-94%. PS was given when FiO2 reached 25% (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be given if necessary if the disease progressed), and PS was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of tracheal intubation and mechanical ventilation	The duration of invasive mechanical ventilation was observed	The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months
Time of first PS use	The time from the first use of PS to birth was observed	Time to first use of pulmonary surfactant within 6 hours after birth
Duration of noninvasive assisted ventilation	The duration of noninvasive mechanical ventilation was observed during hospitalization	Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months
Repeat PS usage rate	Whether PS was used repeatedly during hospitalization was observed	The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth
Days of Oxygen therapy	The time of oxygen therapy during hospitalization was observed	The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months
Failure rate of noninvasive treatment	The use of invasive mechanical ventilation after birth was observed	72 hours after birth

Collaborators and Investigators

• Sponsor: Xu Falin
• Collaborators: Nanyang Central Hospital; Xinyang Central Hospital; Xinxiang Central Hospital; Zhengzhou Central Hospital; Zhoukou Central Hospital; Zhumadian Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 2025-242-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No