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Trial record 34 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

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ClinicalTrials.gov Identifier: NCT03591796
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 22, 2019
Sponsor:
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
First Hospital of Tsinghua University
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
First Affiliated Hospital of Chongqing Medical University
Quanzhou Children's Hospital
Xiamen Maternity & Child Care Hospital
Zhujiang Hospital
Guangdong Academy of Medical Science and General Hospital
Guangdong Women and Children Hospital
Women and Children’s Health Hospital of Yulin
Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous
Second Affiliated Hospital of Guangzhou Medical University
Guiyang Maternal and Child Health Care Hospital
Zunyi First People's Hospital
Second Hospital of Lanzhou University
Gansu Provincial Maternity and Child-Care Hospital
LanZhou University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Xinjiang Medical University
Zhengzhou Children's Hospital, China
Third Affiliated Hospital of Zhengzhou University
the Maternal and Child Health Hospital of Hainan Province
Bethune International Peace Hospital
Wuhan Union Hospital, China
Children’s Hospital of Nanjing Medical University
First Hospital of Jilin University
Children's Hospital of Fudan University
Maternal and Children’s Healthcare Hospital of Taian
The Second Hospital of Shandong University
Shanxi Provincial Maternity and Children's Hospital
Chengdu Women and Children's Center Hospital
The Affiliated Hospital Of Southwest Medical University
Affiliated Hospital of Southwest Medical University
Shenzhen People’s Hospital, The Second Medical College of Jinan University
Tianjin Central Hospital of Gynecology Obstetrics
People's Hospital of Xinjiang Uygur Autonomous Region
Kunming Children's Hospital
The First People's Hospital of Yunnan
The First Affiliated Hospital of Kunming Medical College
Yan’an Hospital Affiliated to Kunming Medical University
Women and Children’s Health Hospital of Qujing
The People's Hospital of Dehong Autonomous Prefecture
Yinchuan No 1 people’s Hospital Affiliated of Ningxia Medical University
The Children's Hospital of Zhejiang University School of Medicine
Women's Hospital School Of Medicine Zhejiang University
Beijing 302 Hospital
Hunan Children's Hospital
Women and Children Hospital of Qinghai Province
Jiangxi Province Children's Hospital
Inner Mongolia People's Hospital
Mianyang Central Hospital
People's Liberation Army No.202 Hospital
Ningbo Women & Children's Hospital
Shanghai Children's Medical Center
First Affiliated Hospital of Guangxi Medical University
Nanjing Medical University
Qinhuangdao Maternal and Child Health Care Hospital
Xuzhou Children Hospital
The First Affiliated Hospital of Zhengzhou University
Xianyang children’s Hospital
Information provided by (Responsible Party):
Chen Long,MD, Children's Hospital of Chongqing Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Conventional Mechanical Ventilation High Frequency Oscillation Ventilation Device: HFOV Device: CMV Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022


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.




Primary Outcome Measures :
  1. the incidence of bronchopulmonary dysplasia (BPD) [ Time Frame: 28 days after birth or 36 weeks'gestational age ]
    the included neonate was diagnosed with BPD

  2. Death [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included preterm infants were dead


Secondary Outcome Measures :
  1. the incidence of neonatal necrotizing enterocolitis(NEC) [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included neonate was diagnosed with NEC

  2. the incidence of retinopathy of prematurity(ROP) [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included neonate was diagnosed with ROP

  3. Intraventricular hemorrhage [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    Intraventricular hemorrhage was diagnosed

  4. composite mortality/BPD [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    composite mortality/BPD was diagnosed

  5. the incidence of airleak [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included neonate was diagnosed with airleak



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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age (GA) between 26+0 and 32+0 weeks;
  • Birth weight less than 2000g;
  • Assisted with CMV within 12 h after birth;
  • Diagnosis with ARDS and/or RDS;
  • Stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O; 90%-95% of SpO2

Exclusion Criteria:

  • Neonates who only needed noninvasive ventilation;
  • Major congenital anomalies or chromosomal abnormalities;
  • Neuromuscular diseases;
  • Upper respiratory tract abnormalities;
  • Need for surgery known before the first extubation;
  • Grade Ⅲ-IV-intraventricular hemorrhage (IVH);
  • Congenital lung diseases or malformations or pulmonary hypoplasia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591796


Locations
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China, Chongqing
Children's Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Long Chen, MD    8613883559467    neuroclong@126.com   
Contact: Shi Yuan, PhD,MD    13508300283    petshi530@vip.163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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
First Hospital of Tsinghua University
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
First Affiliated Hospital of Chongqing Medical University
Quanzhou Children's Hospital
Xiamen Maternity & Child Care Hospital
Zhujiang Hospital
Guangdong Academy of Medical Science and General Hospital
Guangdong Women and Children Hospital
Women and Children’s Health Hospital of Yulin
Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous
Second Affiliated Hospital of Guangzhou Medical University
Guiyang Maternal and Child Health Care Hospital
Zunyi First People's Hospital
Second Hospital of Lanzhou University
Gansu Provincial Maternity and Child-Care Hospital
LanZhou University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Xinjiang Medical University
Zhengzhou Children's Hospital, China
Third Affiliated Hospital of Zhengzhou University
the Maternal and Child Health Hospital of Hainan Province
Bethune International Peace Hospital
Wuhan Union Hospital, China
Children’s Hospital of Nanjing Medical University
First Hospital of Jilin University
Children's Hospital of Fudan University
Maternal and Children’s Healthcare Hospital of Taian
The Second Hospital of Shandong University
Shanxi Provincial Maternity and Children's Hospital
Chengdu Women and Children's Center Hospital
The Affiliated Hospital Of Southwest Medical University
Affiliated Hospital of Southwest Medical University
Shenzhen People’s Hospital, The Second Medical College of Jinan University
Tianjin Central Hospital of Gynecology Obstetrics
People's Hospital of Xinjiang Uygur Autonomous Region
Kunming Children's Hospital
The First People's Hospital of Yunnan
The First Affiliated Hospital of Kunming Medical College
Yan’an Hospital Affiliated to Kunming Medical University
Women and Children’s Health Hospital of Qujing
The People's Hospital of Dehong Autonomous Prefecture
Yinchuan No 1 people’s Hospital Affiliated of Ningxia Medical University
The Children's Hospital of Zhejiang University School of Medicine
Women's Hospital School Of Medicine Zhejiang University
Beijing 302 Hospital
Hunan Children's Hospital
Women and Children Hospital of Qinghai Province
Jiangxi Province Children's Hospital
Inner Mongolia People's Hospital
Mianyang Central Hospital
People's Liberation Army No.202 Hospital
Ningbo Women & Children's Hospital
Shanghai Children's Medical Center
First Affiliated Hospital of Guangxi Medical University
Nanjing Medical University
Qinhuangdao Maternal and Child Health Care Hospital
Xuzhou Children Hospital
The First Affiliated Hospital of Zhengzhou University
Xianyang children’s Hospital

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Responsible Party: Chen Long,MD, Principal Investigator, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03591796     History of Changes
Other Study ID Numbers: invasive ventilation for ARDS
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury