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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109162
Enrollment
Unknown
Registered
2025-09-14
Start date
2025-09-14
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal respiratory distress syndrome

Interventions

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 cmH2
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

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1: Very preterm infants with gestational age <32 weeks 2: immediately transferred to the neonatal intensive care unit 3: signs of respiratory distress or RDS requiring respiratory support; 4: Informed consent was obtained from the families of the children.

Exclusion criteria

Exclusion criteria: 1: Giving up treatment or being transferred to other hospitals during hospitalization; 2: requiring mechanical ventilation with tracheal intubation immediately or within 2 hours after birth 3: complicated with pneumothorax, complex congenital heart disease, congenital malformation, congenital cystic lung disease, chromosomal inherited metabolic diseases, etc 4: Incomplete clinical data

Design outcomes

Primary

MeasureTime frame
Duration of tracheal intubation and mechanical ventilation;Time of first PS use;Duration of noninvasive assisted ventilation;Repeat PS usage rate;Days of Oxygen therapy;Failure rate of noninvasive treatment;

Countries

China

Contacts

Public ContactXu Falin

The Third Affiliated Hospital of Zhengzhou University

xufalin72@126.com+86 136 6381 3928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026