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Nasal intermittent positive pressure ventilation reduces the need for invasive ventilation in very premature infants: a single-center randomized controlled study

Nasal intermittent positive pressure ventilation reduces the need for invasive ventilation in very premature infants: a single-center randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049622
Enrollment
Unknown
Registered
2021-08-07
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

neonatal respiratory distress syndrome (NRDS)

Interventions

Group 1:nasal intermittent positive pressure ventilation
Group 2:nasal continuous positive pressure ventilation

Sponsors

Shanghai First Maternity and Infant Hospital, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The gestational age at birth is less than 32 weeks, and the daily age is less than or equal to 6 hours (the assessment of gestational age is based on the first trimester ultrasound and the last menstrual period of the pregnant woman); 2. Progressive respiratory distress-related manifestations within 6 hours, with at least 2 of the following manifestations: shortness of breath (breath rate > 60 breaths/min), alar flap, moaning, three concave sign (suprasternal fossa, intercostal space, subxiphoid) positive, cyanosis and consistent with NRDS findings on chest X-ray or lung ultrasonography within 6 hours after birth; 3. Active spontaneous breathing; 4. Description of special circumstances: (1) Those who needed tracheal intubation resuscitation in the delivery room but were active spontaneously breathing after arriving in the ward were included in the study; (2) Invasive ventilation was given to patients with weak spontaneous breathing after birth, but active spontaneous breathing within 6 hours after birth. Clinicians considered that they could meet the indications of non-invasive ventilation and were included in the study.

Exclusion criteria

Exclusion criteria: 1. Death within 6 hours of admission or transfer due to insufficient beds; 2. Combined with cyanotic heart disease, diaphragmatic hernia, major congenital malformation or chromosomal abnormality, neuromuscular disease.

Design outcomes

Primary

MeasureTime frame
Incidence of Intrusive mechanical ventilation;The incidence of bronchopulmonary dysplasia;

Countries

China

Contacts

Public ContactWang Tingting

Shanghai First Maternity and Infant Hospital, Tongji University

wangttkycg@126.com+86 18721735187

Outcome results

None listed

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