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A randomized controlled trial: invasive high-frequency oscillatory ventilation vs. high-frequency oscillatory ventilation combined with volume-guarantee for NRDS

A randomized controlled trial: invasive high-frequency oscillatory ventilation vs. high-frequency oscillatory ventilation combined with volume-guarantee for NRDS

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052839
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Neonatal Respiratory Distress Syndrom

Interventions

HFOV group:Invasive high-frequency oscillatory ventilation
HFOV-VG group:high-frequency oscillatory ventilation combined with volume-guarantee

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newborns diagnosed with respiratory distress syndrome within 12 hours after birth and requiring tracheal intubation for high-frequency oscillatory ventilator treatment; 2. Gestational age >= 28 weeks; 3. Patients who started receiving non-invasive ventilation within 12 hours after birth, but changed to invasive high-frequency oscillatory ventilation within 3 days after birth; 4. The children's family members agreed to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Complex congenital heart disease, congenital gastrointestinal malformations, congenital airway malformations, congenital nervous system malformations, genetic metabolic diseases, genetic diseases, etc.; 2. Severe asphyxia and aEEG still abnormal or accompanying with obvious symptoms of neurological damage at 72 hours after birth; 3. With various reasons of shock, anti-shock treatment was unsuccessful pesisting for half an hour.

Design outcomes

Primary

MeasureTime frame
Bronchopulmonary dysplasia;Death at 36 gestatinal weeks;

Secondary

MeasureTime frame
Intraventricular hemorrage;Periventricular white matter softening;

Countries

China

Contacts

Public ContactShi Yuan

Children's Hospital of Chongqing Medical University

petshi530@vip.163.com+86 13508300283

Outcome results

None listed

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