Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome (ARDS) and/or RDS : a Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    400
  • sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Updated on 22 October 2022
respiratory distress
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, Bronchopulmonary Dysplasia, High Frequency Oscillation Ventilation
Treatment HFOV, CMV, CMV
Clinical Study IdentifierNCT03372525
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) between 26+0 and 32+0 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); (2)Birth weight less than 2000g; (3) assisted with CMV within 12 h after birth; (4)diagnosis with ARDS and/or RDS. (5)stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O

Exclusion Criteria

neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) congenital lung diseases or malformations or pulmonary hypoplasia
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