Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07235345

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhengzhou University

Henan, Zhengzhou, 455000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Duration of tracheal intubation and mechanical ventilation

    Time frame: The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months

    The duration of invasive mechanical ventilation was observed

  2. Time of first PS use

    Time frame: Time to first use of pulmonary surfactant within 6 hours after birth

    The time from the first use of PS to birth was observed

  3. Duration of noninvasive assisted ventilation

    Time frame: Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months

    The duration of noninvasive mechanical ventilation was observed during hospitalization

  4. Repeat PS usage rate

    Time frame: The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth

    Whether PS was used repeatedly during hospitalization was observed

  5. Days of Oxygen therapy

    Time frame: The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months

    The time of oxygen therapy during hospitalization was observed

  6. Failure rate of noninvasive treatment

    Time frame: 72 hours after birth

    The use of invasive mechanical ventilation after birth was observed

Sponsors and collaborators

Lead sponsor

Xu Falin

Other

Collaborators

  • Nanyang Central Hospital
  • Xinxiang Central Hospital
  • Xinyang Central Hospital
  • Zhengzhou Central Hospital
  • Zhoukou Central Hospital
  • Zhumadian Central Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.