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 : February 16, 2021

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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

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

The First Affiliated Hospital of Kunming Medical College

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

Information provided by (Responsible Party):

Chen Long,MD, Children's Hospital of Chongqing Medical University

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.

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	646 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
Actual Study Start Date :	January 1, 2019
Estimated Primary Completion Date :	December 12, 2022
Estimated Study Completion Date :	December 12, 2022

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

death [ Time Frame: 36 weeks' gestational age ]
the included neonates were dead
the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2 [ Time Frame: 36 weeks' gestational age ]
the included neonates need to being supported by ECMO
the incidence of bronchopulmonary dysplasia(BPD) [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with BPD

Secondary Outcome Measures :

the incidence of retinopathy of prematurity(ROP) [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with ROP
the incidence of necrotizing enterocolitis(NEC) [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with NEC
duration of invasive ventilation [ Time Frame: 36 weeks' gestational age ]
duration of invasive ventilation for HFOV or CMV
air leak (pneumothorax and/or pneumomediastinum) occurred [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with air leak
intraventricular hemorrhage(IVH)>2nd grade [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with IVH>2nd grade
composite mortality/BPD [ Time Frame: 36 weeks' gestational age ]
the included neonates were diagnosed with composite mortality/BPD
the success rate of extubation [ Time Frame: 36 weeks' gestational age ]
the included neonates wean from invasive ventilation

Eligibility Criteria

Information from the National Library of Medicine

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Layout table for eligibility information

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

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

Contacts and Locations