Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    600
  • sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Updated on 23 October 2022
acute respiratory distress
FIO2
assisted breathing
assisted ventilation

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.

Description

Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.

Details
Condition Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
Treatment HFOV, CMV
Clinical Study IdentifierNCT03591796
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gestational age (GA) between 26+0 and 32+0 weeks
Birth weight less than 2000g
Assisted with CMV within 12 h after birth
Diagnosis with ARDS and/or RDS
Stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O; 90%-95% of SpO2

Exclusion Criteria

Neonates who only needed noninvasive ventilation
Major congenital anomalies or chromosomal abnormalities
Neuromuscular diseases
Upper respiratory tract abnormalities
Need for surgery known before the first extubation
Grade Ⅲ-IV-intraventricular hemorrhage (IVH)
Congenital lung diseases or malformations or pulmonary hypoplasia
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