RecruitingNot Applicable

High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial

China400 participantsStarted 2025-10-01

Plain-language summary

Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.

Who can participate

Age range1 Minute – 1 Hour

SexALL

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Inclusion criteria

✓. GA was between 24+0 and 31+6 weeks.
✓. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.
✓. Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \> 7.20, PaCO2 60 mmHg, tidal volume of 5 ml/kg and \> 35% of hematocrit (these may be evaluated by arterial blood gas analysis).

Exclusion criteria

✕. Parents or guardians' decision not to participate.
✕. Major congenital anomalies or chromosomal abnormalities
✕. Need for surgery or more than grade 2nd of IVH before randomization.

What they're measuring

the incidence of bronchopulmonary dysplasia(BPD)

Timeframe: 36 weeks' gestational age

Trial details

NCT IDNCT03736707

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials