To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations o… (NCT07235345) | Clinical Trial Compass
By InvitationNot Applicable
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
China500 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
Age range
26 Weeks – 32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of tracheal intubation and mechanical ventilation
Timeframe: The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months
2
Time of first PS use
Timeframe: Time to first use of pulmonary surfactant within 6 hours after birth
3
Duration of noninvasive assisted ventilation
Timeframe: Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months
4
Repeat PS usage rate
Timeframe: The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth
5
Days of Oxygen therapy
Timeframe: The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months