Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates

Overview

Neonatal respiratory distress syndrome (RDS) remains a major respiratory disorder for the increasing preterm population, and its incidence has been confirmed to be increased gradually with decreased gestational age. Previous studies demonstrated incidences of 90% at 24 weeks', 80% at 28 weeks', 57% at 30-31 weeks', and 25% at 35-36 weeks' gestational age(GA). However, these figures were mainly performed in the pre-neonatal acute respiratory distress syndrome (ARDS) era, in which ARDS was usually considered as RDS, and surfactant was therefore used repeatedly. In fact, no studies have indicated beneficial effects of surfactant for adult and pediatric ARDS, and therefore, its exact action for neonatal ARDS was needed to be further elucidated. In 2017, the international ARDS collaborative group provided the first consensus definition for neonatal ARDS, and the exact incidence of neonatal ARDS and mortality were unknown.

Full Title of Study: “Elective High Frequency Oscillatory Ventilation (HFOV) Versus Conventional Mechanical Ventilation(CMV) for Acute Respiratory Distress Syndrome(ARDS) and/or Respiratory Distress Syndrome(RDS) in Neonates:a Multicenter Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2020

Detailed Description

Similarities to adult and pediatric ARDS, no special pharmacologic therapy for neonatal ARDS has been shown to reduce either short-term or long-term mortality and morbidity, the risk of death therefore remains high for preterm infants. Study reported that 50% chance of death with neonatal intensive care appeared at 24 weeks in most high-income countries and 34 in low-income and middle-income countries. Among the survivors, bronchopulmonary dysplasia(BPD), neurologic impairment and retinopathy of prematurity(ROP) were the main causes of secondary death, rehospitalization and medical resource use. How to reduce rate of mortality and severe complications constitutes a challenge for neonatologists.

An interesting result was that HFOV did reduce the incidence of mortality as compared with CMV(2:9 vs 3:3, 95%confidence intervel(CI) 0.09-0.89, P=0.03) (4:177 vs 13:179, 95%CI 0.10-0.94, P=0.04). The results suggested that, excluding preterm infants with RDS, HFOV could also reduce other primary outcomes, such as the risk of death, BPD, IVH and neurologic impairment.

Interventions

  • Device: Selective HFOV
    • Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase
  • Device: CMV
    • CMV was delivered by time-cycled, pressure-limited ventilators

Arms, Groups and Cohorts

  • Experimental: Selective HFOV
    • Selective HFOV will be provided
  • Active Comparator: CMV
    • CMV will be provided

Clinical Trial Outcome Measures

Primary Measures

  • death
    • Time Frame: 36 weeks’ gestational age or before discharge from hospital
    • the included neonates were dead
  • the incidence of extracorporeal membrane oxygenation(ECMO)
    • Time Frame: 36 weeks’ gestational age or before discharge from hospital
    • the included neonates need to being supported by ECMO

Secondary Measures

  • the incidence of bronchopulmonary dysplasia(BPD)
    • Time Frame: 36 weeks’ gestational age or before discharge from hospital
    • the included neonates were diagnosed with BPD
  • the incidence of retinopathy of prematurity(ROP)
    • Time Frame: 36 weeks’ gestational age or before discharge from hospital
    • the included neonates were diagnosed with ROP
  • the incidence of necrotizing enterocolitis(NEC)
    • Time Frame: 36 weeks’ gestational age or before discharge from hospital
    • the included neonates were diagnosed with NEC

Participating in This Clinical Trial

Inclusion Criteria

  • For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) > 32+0 weeks ; (2)Birth weight>2000g; (3) diagnosis with ARDS and/or RDS. (4) assisted with CMV within 12 h after birth; (5)stabilization before randomization within 12 h after birth: FiO2<0.30, Paw<15 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Collaborator
    • Children’s Hospital of Chongqing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chen Long,MD, Principal Investigator – Children’s Hospital of Chongqing Medical University

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