Clinical study for different non-invasive respiratory support modes combined with less invasive surfactant administration in premature infants with respiratory distress syndrome

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026374

Enrollment

Unknown

Registered

2019-10-04

Start date

2019-12-31

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Respiratory distress syndrome

Interventions

Group 1:nHFOV

Group 2:nIPPV

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The gestational age ranged from 25 + 0 weeks to 31 + 6 weeks, and the birth weight ranged from 600 g to 1500 g. 2. Postnatal non-invasive ventilation support due to dyspnea, including nCPAP, nIPPV and nHFOV. 3. Within 24 hours after birth. 4. The need for pulmonary surfactant therapy. 5. Parents sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Need intubation before trial; 2. Obvious congenital malformations or chromosomal diseases; 3. Neuromuscular diseases affecting respiratory function; 4. Congenital pulmonary infection or pulmonary dysplasia.

Design outcomes

Secondary

Measure	Time frame
Intubation rate;Duration of non-invasive ventilation;Pneumothorax;NEC (stage II and above);PDA;IVH (grade 3 and above);Nasal injury;	—

Primary

Measure	Time frame
Incidence and extent of bronchopulmonary dysplasia;Mortality at 36 weeks of corrected gestational age;	—

Countries

China

Contacts

Public ContactZhiqun Zhang

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

zhiqun.zhang@163.com+86 13989453622

Outcome results

None listed

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