Back to resultsInvasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)
Primary Purpose
Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HFOV
CMV
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility 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.
Sites / Locations
- Children's Hospital of Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HFOV
CMV
Arm Description
Ventilated infants were randomized to HFOV.
Ventilated infants were randomized to CMV.
Outcomes
Primary Outcome Measures
the incidence of bronchopulmonary dysplasia (BPD)
the included neonate was diagnosed with BPD
Death
the included preterm infants were dead
Secondary Outcome Measures
the incidence of neonatal necrotizing enterocolitis(NEC)
the included neonate was diagnosed with NEC
the incidence of retinopathy of prematurity(ROP)
the included neonate was diagnosed with ROP
Intraventricular hemorrhage
Intraventricular hemorrhage was diagnosed
composite mortality/BPD
composite mortality/BPD was diagnosed
the incidence of airleak
the included neonate was diagnosed with airleak
Full Information
NCT ID
NCT03591796
First Posted
July 9, 2018
Last Updated
April 28, 2023
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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, The First People's Hospital of Zunyi, Second Hospital of Lanzhou University, Gansu Provincial Maternal and Child Health 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, The 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, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of 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
1. Study Identification
Unique Protocol Identification Number
NCT03591796
Brief Title
Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no participants were included
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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, The First People's Hospital of Zunyi, Second Hospital of Lanzhou University, Gansu Provincial Maternal and Child Health 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, The 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, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HFOV
Arm Type
Experimental
Arm Description
Ventilated infants were randomized to HFOV.
Arm Title
CMV
Arm Type
Active Comparator
Arm Description
Ventilated infants were randomized to CMV.
Intervention Type
Device
Intervention Name(s)
HFOV
Intervention Description
Ventilated infants were randomized to HFOV
Intervention Type
Device
Intervention Name(s)
CMV
Intervention Description
Ventilated infants were randomized to CMV.
Primary Outcome Measure Information:
Title
the incidence of bronchopulmonary dysplasia (BPD)
Description
the included neonate was diagnosed with BPD
Time Frame
28 days after birth or 36 weeks'gestational age
Title
Death
Description
the included preterm infants were dead
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
Secondary Outcome Measure Information:
Title
the incidence of neonatal necrotizing enterocolitis(NEC)
Description
the included neonate was diagnosed with NEC
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
Title
the incidence of retinopathy of prematurity(ROP)
Description
the included neonate was diagnosed with ROP
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
Title
Intraventricular hemorrhage
Description
Intraventricular hemorrhage was diagnosed
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
Title
composite mortality/BPD
Description
composite mortality/BPD was diagnosed
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
Title
the incidence of airleak
Description
the included neonate was diagnosed with airleak
Time Frame
28 days after birth or 36 weeks'gestational age or before discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Learn more about this trial
Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)
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