Back to resultsSelective High Frequency Oscillatory Ventilation (HFOV) for Neonates
Primary Purpose
Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Selective HFOV
CMV
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
subgroup 1: For a neonate to be included, the following four criteria must be fulfilled:
- gestational age (GA) between 26+0 and 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);
- birth weight less than 2000g;
- diagnosis with ARDS and/or RDS;
- assisted with CMV within 12 h after birth;
- stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis).
subgroup 2 For a neonate to be included, the following four criteria must be fulfilled:
- gestational age (GA) more than 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);
- birth weight more than 2000g;
- diagnosis with ARDS and/or RDS;
- assisted with CMV within 12 h after birth;
- stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis).
Exclusion Criteria:
Neonates with at least one of the following criteria are not eligible for the study:
- 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.
- parents reject to join
Sites / Locations
- Children's Hospital of Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Selective HFOV
CMV
Arm Description
Selective HFOV will be provided
CMV will be provided
Outcomes
Primary Outcome Measures
death
the included neonates were dead
the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2
the included neonates need to being supported by ECMO
the incidence of bronchopulmonary dysplasia(BPD)
the included neonates were diagnosed with BPD
Secondary Outcome Measures
the incidence of retinopathy of prematurity(ROP)
the included neonates were diagnosed with ROP
the incidence of necrotizing enterocolitis(NEC)
the included neonates were diagnosed with NEC
duration of invasive ventilation
duration of invasive ventilation for HFOV or CMV
air leak (pneumothorax and/or pneumomediastinum) occurred
the included neonates were diagnosed with air leak
intraventricular hemorrhage(IVH)>2nd grade
the included neonates were diagnosed with IVH>2nd grade
composite mortality/BPD
the included neonates were diagnosed with composite mortality/BPD
the success rate of extubation
the included neonates wean from invasive ventilation
Full Information
NCT ID
NCT03736707
First Posted
November 7, 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, Nanfang Hospital, Southern Medical University, 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, Xianyang Children's Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03736707
Brief Title
Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates
Official Title
Elective High Frequency Oscillatory Ventilation (HFOV) Versus Conventional Mechanical Ventilation(CMV) for Acute Respiratory Distress Syndrome(ARDS) and/or Respiratory Distress Syndrome(RDS) in Neonates：a Multicenter Randomized 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
January 1, 2019 (Actual)
Primary Completion Date
December 12, 2024 (Anticipated)
Study Completion Date
December 12, 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, Nanfang Hospital, Southern Medical University, 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, Xianyang Children's Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children 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
Neonatal respiratory distress syndrome (RDS) remains a major respiratory disorder for the increasing preterm population, and its incidence has been confirmed to be increased gradually with decreased gestational age. Previous studies demonstrated incidences of 90% at 24 weeks', 80% at 28 weeks', 57% at 30-31 weeks', and 25% at 35-36 weeks' gestational age(GA). However, these figures were mainly performed in the pre-neonatal acute respiratory distress syndrome (ARDS) era, in which ARDS was usually considered as RDS, and surfactant was therefore used repeatedly. In fact, no studies have indicated beneficial effects of surfactant for adult and pediatric ARDS, and therefore, its exact action for neonatal ARDS was needed to be further elucidated. In 2017, the international ARDS collaborative group provided the first consensus definition for neonatal ARDS, and the exact incidence of neonatal ARDS and mortality were unknown.
Detailed 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Neonates will be randomized and assigned either to selective HFOV or CMV
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selective HFOV
Arm Type
Experimental
Arm Description
Selective HFOV will be provided
Arm Title
CMV
Arm Type
Active Comparator
Arm Description
CMV will be provided
Intervention Type
Device
Intervention Name(s)
Selective HFOV
Intervention Description
Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase
Intervention Type
Device
Intervention Name(s)
CMV
Intervention Description
CMV was delivered by time-cycled, pressure-limited ventilators
Primary Outcome Measure Information:
Title
death
Description
the included neonates were dead
Time Frame
36 weeks' gestational age
Title
the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2
Description
the included neonates need to being supported by ECMO
Time Frame
36 weeks' gestational age
Title
the incidence of bronchopulmonary dysplasia(BPD)
Description
the included neonates were diagnosed with BPD
Time Frame
36 weeks' gestational age
Secondary Outcome Measure Information:
Title
the incidence of retinopathy of prematurity(ROP)
Description
the included neonates were diagnosed with ROP
Time Frame
36 weeks' gestational age
Title
the incidence of necrotizing enterocolitis(NEC)
Description
the included neonates were diagnosed with NEC
Time Frame
36 weeks' gestational age
Title
duration of invasive ventilation
Description
duration of invasive ventilation for HFOV or CMV
Time Frame
36 weeks' gestational age
Title
air leak (pneumothorax and/or pneumomediastinum) occurred
Description
the included neonates were diagnosed with air leak
Time Frame
36 weeks' gestational age
Title
intraventricular hemorrhage(IVH)>2nd grade
Description
the included neonates were diagnosed with IVH>2nd grade
Time Frame
36 weeks' gestational age
Title
composite mortality/BPD
Description
the included neonates were diagnosed with composite mortality/BPD
Time Frame
36 weeks' gestational age
Title
the success rate of extubation
Description
the included neonates wean from invasive ventilation
Time Frame
36 weeks' gestational age
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:
subgroup 1: For a neonate to be included, the following four criteria must be fulfilled:
gestational age (GA) between 26+0 and 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);
birth weight less than 2000g;
diagnosis with ARDS and/or RDS;
assisted with CMV within 12 h after birth;
stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis).
subgroup 2 For a neonate to be included, the following four criteria must be fulfilled:
gestational age (GA) more than 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);
birth weight more than 2000g;
diagnosis with ARDS and/or RDS;
assisted with CMV within 12 h after birth;
stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis).
Exclusion Criteria:
Neonates with at least one of the following criteria are not eligible for the study:
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.
parents reject to join
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
Plan to Share IPD
No
Learn more about this trial
Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates
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