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

RecruitingNAAges 1 Minute - 1 HourAllDaping Hospital and the Research Institute of Sur…
NCT03736707 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion criteria 1. GA was between 24+0 and 31+6 weeks. 2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV. 3. 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 Neonates were not included if any of the following criteria were met: 1. Parents or guardians' decision not to participate. 2. Major congenital anomalies or chromosomal abnormalities 3. Need for surgery or more than grade 2nd of IVH before randomization.
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What it tests

  • HFOV
  • CMV
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Where

1 site
Children's Hospital of Chongqing Medical University
Chongqing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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