Neonatal Respiratory Distress SyndromeNCT07235345
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 study testing According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold in people with Neonatal Respiratory Distress Syndrome, run by Xu Falin at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 26 to 32 weeks
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- What is being tested?
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 455000
About this study
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.
Read the 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.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the thresholdOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of tracheal intubation and mechanical ventilation
The duration of invasive mechanical ventilation was observed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start4 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Falin
- Sponsor type
- University, hospital or other
- Collaborators
- Zhumadian Central Hospital, Zhengzhou Central Hospital, Xinyang Central Hospital, Xinxiang Central Hospital, Nanyang Central Hospital, Zhoukou Central Hospital
- Responsible party
- Sponsor-investigator, Xu Falin, Third Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235345
- Sponsor's protocol ID
- 2025-242-01
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No