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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Conventional Mechanical Ventilation; High Frequency Oscillation Ventilation
• Intervention / Treatment: Device: HFOV; Device: CMV

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Children's Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 12 hours (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFOV; Ventilated infants were randomized to HFOV.	Device: HFOV; Ventilated infants were randomized to HFOV
Active Comparator: CMV; Ventilated infants were randomized to CMV.	Device: CMV; Ventilated infants were randomized to CMV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of bronchopulmonary dysplasia (BPD)	the included neonate was diagnosed with BPD	28 days after birth or 36 weeks'gestational age
Death	the included preterm infants were dead	28 days after birth or 36 weeks'gestational age or before discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of neonatal necrotizing enterocolitis(NEC)	the included neonate was diagnosed with NEC	28 days after birth or 36 weeks'gestational age or before discharge
the incidence of retinopathy of prematurity(ROP)	the included neonate was diagnosed with ROP	28 days after birth or 36 weeks'gestational age or before discharge
Intraventricular hemorrhage	Intraventricular hemorrhage was diagnosed	28 days after birth or 36 weeks'gestational age or before discharge
composite mortality/BPD	composite mortality/BPD was diagnosed	28 days after birth or 36 weeks'gestational age or before discharge
the incidence of airleak	the included neonate was diagnosed with airleak	28 days after birth or 36 weeks'gestational age or before discharge

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: The First Affiliated Hospital of Anhui Medical University; LanZhou University; Beijing 302 Hospital; Peking University Third Hospital; The First Affiliated Hospital of Zhengzhou University; Children's Hospital of Fudan University; Shanghai Children's Medical Center; Zhujiang Hospital; The First Hospital of Jilin University; Women's Hospital School Of Medicine Zhejiang University; Wuhan Union Hospital, China; People's Hospital of Xinjiang Uygur Autonomous Region; The Second Hospital of Shandong University; Nanjing Medical University; Second Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital of Xinjiang Medical University; Bethune International Peace Hospital; Kunming Children's Hospital; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Harbin Medical University; Hunan Children's Hospital; Guangdong Women and Children Hospital; Xiamen Maternity & Child Care Hospital; Inner Mongolia People's Hospital; The Affiliated Hospital Of Southwest Medical University; The Children's Hospital of Zhejiang University School of Medicine; Jiangxi Province Children's Hospital; Mianyang Central Hospital; Zhengzhou Children's Hospital, China; Quanzhou Children's Hospital; Children's Hospital of Chongqing Medical University; Tianjin Central Hospital of Gynecology Obstetrics; First Affiliated Hospital of Guangxi Medical University; The First People's Hospital of Yunnan; Shanxi Provincial Maternity and Children's Hospital; Yan'an Affiliated Hospital of Kunming Medical University; Children's Hospital of Nanjing Medical University; Third Affiliated Hospital of Zhengzhou University; Affiliated Hospital of Southwest Medical University; Chongqing Maternal and Child Health Hospital; First Hospital of Tsinghua University; The First People's Hospital of Zunyi; Chengdu Women and Children's Center Hospital; Lanzhou University Second Hospital; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region; Ningbo Women & Children's Hospital; Xianyang Children's Hospital; Jiulongpo No.1 People's Hospital; Children's Hospital of The Capital Institute of Pediatrics; Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital; Guangdong Academy of Medical Science and General Hospital; Women and Children's Health Hospital of Yulin; Guiyang Maternal and Child Health Care Hospital; the Maternal and Child Health Hospital of Hainan Province; Maternal and Children's Healthcare Hospital of Taian; Shenzhen People's Hospital, The Second Medical College of Jinan University; Women and Children's Health Hospital of Qujing; The People's Hospital of Dehong Autonomous Prefecture; Women and Children Hospital of Qinghai Province; People's Liberation Army No.202 Hospital; Qinhuangdao Maternal and Child Health Care Hospital; Xuzhou Children Hospital; First Affiliated Hospital of Kunming Medical University; The First People's Hospital of Yinchuan; Gansu Provincial Maternal and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: invasive ventilation for ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
• IPD Sharing Time Frame: after accepted
• IPD Sharing Access Criteria: email to the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No