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Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates

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ClinicalTrials.gov Identifier: NCT03736707
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
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
Nanfang Hospital of 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
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
Xianyang children’s Hospital
Qinhuangdao Maternal and Child Health Care Hospital
Xuzhou Children Hospital
Information provided by (Responsible Party):
Chen Long,MD, Children's Hospital of Chongqing Medical University

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Neonates will be randomized and assigned either to selective HFOV or CMV
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Selective HFOV
Selective HFOV will be provided
Device: Selective HFOV
Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase

Active Comparator: CMV
CMV will be provided
Device: CMV
CMV was delivered by time-cycled, pressure-limited ventilators




Primary Outcome Measures :
  1. death [ Time Frame: 36 weeks' gestational age or before discharge from hospital ]
    the included neonates were dead

  2. the incidence of extracorporeal membrane oxygenation(ECMO) [ Time Frame: 36 weeks' gestational age or before discharge from hospital ]
    the included neonates need to being supported by ECMO


Secondary Outcome Measures :
  1. the incidence of bronchopulmonary dysplasia(BPD) [ Time Frame: 36 weeks' gestational age or before discharge from hospital ]
    the included neonates were diagnosed with BPD

  2. the incidence of retinopathy of prematurity(ROP) [ Time Frame: 36 weeks' gestational age or before discharge from hospital ]
    the included neonates were diagnosed with ROP

  3. the incidence of necrotizing enterocolitis(NEC) [ Time Frame: 36 weeks' gestational age or before discharge from hospital ]
    the included neonates were diagnosed with NEC



Information from the National Library of Medicine

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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:

  • For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) > 32+0 weeks ; (2)Birth weight>2000g; (3) diagnosis with ARDS and/or RDS. (4) assisted with CMV within 12 h after birth; (5)stabilization before randomization within 12 h after birth: FiO2<0.30, Paw<15 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg

Exclusion Criteria:

  • Neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) 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): NCT03736707


Locations
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China, Chongqing
Children's Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Shi Yuan, PhD,MD    13508300283 ext 86    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
Nanfang Hospital of 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
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
Xianyang children’s Hospital
Qinhuangdao Maternal and Child Health Care Hospital
Xuzhou Children Hospital

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Responsible Party: Chen Long,MD, Principal Investigator, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03736707     History of Changes
Other Study ID Numbers: NARDS
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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