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

NCT ID: NCT07235345

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High fraction of inspired oxygen

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low fraction of inspired oxygen

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhumadian Central Hospital

OTHER

Sponsor Role: collaborator

Zhengzhou Central Hospital

OTHER

Sponsor Role: collaborator

Xinyang Central Hospital

OTHER

Sponsor Role: collaborator

Xinxiang Central Hospital

OTHER

Sponsor Role: collaborator

Nanyang Central Hospital

OTHER

Sponsor Role: collaborator

Zhoukou Central Hospital

OTHER

Sponsor Role: collaborator

Xu Falin

OTHER

Sponsor Role: lead

Responsible Party

Xu Falin

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Third Affiliated Hospital of Zhengzhou University

Henan, Zhengzhou, China

Countries

China

Other Identifiers

2025-242-01

Identifier Type: -

Identifier Source: org_study_id