Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
400

Summary

Conditions
  • Acute Respiratory Distress Syndrome
  • High Frequency Oscillatory Ventilation
  • Respiratory Distress Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Neonates will be randomized and assigned either to selective HFOV or CMVMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 12 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03736707
Collaborators
  • Children's Hospital of Chongqing Medical University
  • Jiulongpo No.1 People's Hospital
  • Chongqing Maternal and Child Health Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Children's Hospital of The Capital Institute of Pediatrics
  • Peking University Third Hospital
  • Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous
  • Gansu Provincial Maternity and Child-Care Hospital
  • First Hospital of Tsinghua University
  • Children's Hospital of Fudan University
  • Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University
  • Women and Children Hospital of Qinghai Province
  • Ningbo Women & Children's Hospital
  • Affiliated Hospital of Southwest Medical University
  • Wuhan Union Hospital, China
  • Kunming Children's Hospital
  • The First Affiliated Hospital of Kunming Medical College
  • Shanxi Provincial Maternity and Children's Hospital
  • People's Liberation Army No.202 Hospital
  • Qinhuangdao Maternal and Child Health Care Hospital
  • First Affiliated Hospital of Harbin Medical University
  • Bethune International Peace Hospital
  • the Maternal and Child Health Hospital of Hainan Province
  • Nanfang Hospital of Southern Medical University
  • Second Hospital of Lanzhou University
  • Beijing 302 Hospital
  • Yan'an Affiliated Hospital of Kunming Medical University
  • The People's Hospital of Dehong Autonomous Prefecture
  • Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
  • First Affiliated Hospital of Chongqing Medical University
  • Chengdu Women and Children's Center Hospital
  • The First People's Hospital of Yunnan
  • Zhengzhou Children's Hospital, China
  • Nanjing Medical University
  • Second Affiliated Hospital of Guangzhou Medical University
  • Zunyi First People's Hospital
  • Xuzhou Children Hospital
  • The Second Hospital of Shandong University
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Zhujiang Hospital
  • Guangdong Women and Children Hospital
  • Maternal and Children's Healthcare Hospital of Taian
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Women and Children's Health Hospital of Qujing
  • Jiangxi Province Children's Hospital
  • Inner Mongolia People's Hospital
  • Shanghai Children's Medical Center
  • Women and Children's Health Hospital of Yulin
  • Guiyang Maternal and Child Health Care Hospital
  • Children's Hospital of Nanjing Medical University
  • Quanzhou Children's Hospital
  • Xianyang children's Hospital
  • Hunan Children's Hospital
  • Mianyang Central Hospital
  • Third Affiliated Hospital of Zhengzhou University
  • Women's Hospital School Of Medicine Zhejiang University
  • Guangdong Academy of Medical Science and General Hospital
  • LanZhou University
  • Tianjin Central Hospital of Gynecology Obstetrics
  • The First Hospital of Jilin University
  • The Children's Hospital of Zhejiang University School of Medicine
  • Xiamen Maternity & Child Care Hospital
  • The Affiliated Hospital Of Southwest Medical University
  • Shenzhen People's Hospital, The Second Medical College of Jinan University
Investigators
Not Provided