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 | Enrolling By Invitation DMC

• 1 other identifier: 2025-242-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

High fraction of inspired oxygen

NO INTERVENTION

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.

Low fraction of inspired oxygen

EXPERIMENTAL

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

Interventions

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

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.

Low fraction of inspired oxygen

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xu Falin: lead
• Zhumadian Central Hospital: collaborator
• Zhengzhou Central Hospital: collaborator
• Xinyang Central Hospital: collaborator
• Xinxiang Central Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Zhoukou Central Hospital: collaborator

Study Sites (1)

The Third Affiliated Hospital of Zhengzhou University

Henan, Zhengzhou, 455000, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: November 19, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)