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

ConditionsAcute Respiratory Distress Syndrome High Frequency Oscillatory Ventilation Preterm Conventional Mechanical Ventilation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-1

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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.

Eligibility criteria

Qualifiers

GA was between 24+0 and 31+6 weeks.

Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.

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).

Disqualifiers

Parents or guardians' decision not to participate.

Major congenital anomalies or chromosomal abnormalities

Need for surgery or more than grade 2nd of IVH before randomization.

Trial design

Treatments tested in this trial

HFOV
CMV

Treatment groups

400 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Lead sponsor

Children's Hospital of Chongqing Medical University

Sponsor institution

Children's Hospital of Chongqing Medical University

Collaborator

Jiulongpo No.1 People's Hospital

Collaborator

Chongqing Maternal and Child Health Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

Children's Hospital of The Capital Institute of Pediatrics

Collaborator

Peking University Third Hospital

Collaborator

First Hospital of Tsinghua University

Collaborator

Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Quanzhou Children's Hospital

Collaborator

Xiamen Maternity & Child Care Hospital

Collaborator

Zhujiang Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Guangdong Academy of Medical Science and General Hospital

Collaborator

Guangdong Women and Children Hospital

Collaborator

Women and Children's Health Hospital of Yulin

Collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

Guiyang Maternal and Child Health Care Hospital

Collaborator

The First People's Hospital of Zunyi

Collaborator

Lanzhou University Second Hospital

Collaborator

Gansu Provincial Maternal and Child Health Care Hospital

Collaborator

LanZhou University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Zhengzhou Children's Hospital, China

Collaborator

Third Affiliated Hospital of Zhengzhou University

Collaborator

the Maternal and Child Health Hospital of Hainan Province

Collaborator

Bethune International Peace Hospital

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Children's Hospital of Nanjing Medical University

Collaborator

The First Hospital of Jilin University

Collaborator

Children's Hospital of Fudan University

Collaborator

Maternal and Children's Healthcare Hospital of Taian

Collaborator

The Second Hospital of Shandong University

Collaborator

Shanxi Provincial Maternity and Children's Hospital

Collaborator

Chengdu Women and Children's Center Hospital

Collaborator

The Affiliated Hospital Of Southwest Medical University

Collaborator

Affiliated Hospital of Southwest Medical University

Collaborator

Shenzhen People's Hospital, The Second Medical College of Jinan University

Collaborator

Tianjin Central Hospital of Gynecology Obstetrics

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Kunming Children's Hospital

Collaborator

The First People's Hospital of Yunnan

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Yan'an Affiliated Hospital of Kunming Medical University

Collaborator

Women and Children's Health Hospital of Qujing

Collaborator

The People's Hospital of Dehong Autonomous Prefecture

Collaborator

The First People's Hospital of Yinchuan

Collaborator

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

Women's Hospital School Of Medicine Zhejiang University

Collaborator

Beijing 302 Hospital

Collaborator

Hunan Children's Hospital

Collaborator

Women and Children Hospital of Qinghai Province

Collaborator

Jiangxi Province Children's Hospital

Collaborator

Inner Mongolia People's Hospital

Collaborator

Mianyang Central Hospital

Collaborator

People's Liberation Army No.202 Hospital

Collaborator

Ningbo Women & Children's Hospital

Collaborator

Shanghai Children's Medical Center

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Nanjing Medical University

Collaborator

Xianyang Children's Hospital

Collaborator

Qinhuangdao Maternal and Child Health Care Hospital

Collaborator

Xuzhou Children Hospital

Collaborator

Source ClinicalTrials.gov