CompletedNot Applicable

Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)

China386 participantsStarted 2024-12-31

Plain-language summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.

Who can participate

Age range1 Minute – 12 Hours

SexALL

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Inclusion Criteria: * Gestational age (GA) between 25+0 and 34+0 weeks; * Assisted with CMV within 12 h after birth; * Diagnosis with ARDS; * 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 and \> 35% of hematocrit Exclusion Criteria: * parents' decision not to participate; * Major congenital anomalies or chromosomal abnormalities; * Upper respiratory tract abnormalities; * need for surgery before randomization; * Grade Ⅲ-IV-intraventricular hemorrhage (IVH).

What they're measuring

the incidence of bronchopulmonary dysplasia (BPD)

Timeframe: 28 days after birth or 36 weeks'gestational age

Death

Timeframe: 28 days after birth or 36 weeks'gestational age or before discharge

Trial details

NCT IDNCT03591796

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials