An interventional study of According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold in Neonatal Respiratory Distress Syndrome, sponsored by Xu Falin. Enrolling by invitation at 1 site in China. Open to participants aged 26 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Xu Falin · Not applicable, Interventional, and Treatment
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.
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.
1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 161 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 712 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
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Exclusion Criteria:
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.
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.
Duration of tracheal intubation and mechanical ventilation
The duration of invasive mechanical ventilation was observed
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 72 hours after birth
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