Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates

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

Sponsors

Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborator: 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 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

Source Daping Hospital and the Research Institute of Surgery of the Third Military 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.

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.

Overall Status Recruiting
Start Date 2019-01-01
Completion Date 2022-12-12
Primary Completion Date 2022-12-12
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
death 36 weeks' gestational age
the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2 36 weeks' gestational age
the incidence of bronchopulmonary dysplasia(BPD) 36 weeks' gestational age
Secondary Outcome
Measure Time Frame
the incidence of retinopathy of prematurity(ROP) 36 weeks' gestational age
the incidence of necrotizing enterocolitis(NEC) 36 weeks' gestational age
duration of invasive ventilation 36 weeks' gestational age
air leak (pneumothorax and/or pneumomediastinum) occurred 36 weeks' gestational age
intraventricular hemorrhage(IVH)>2nd grade 36 weeks' gestational age
composite mortality/BPD 36 weeks' gestational age
the success rate of extubation 36 weeks' gestational age
Enrollment 646
Condition
Intervention

Intervention Type: Device

Intervention Name: Selective HFOV

Description: Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase

Arm Group Label: Selective HFOV

Intervention Type: Device

Intervention Name: CMV

Description: CMV was delivered by time-cycled, pressure-limited ventilators

Arm Group Label: CMV

Eligibility

Criteria:

Inclusion Criteria: subgroup 1: For a neonate to be included, the following four criteria must be fulfilled: 1. gestational age (GA) between 26+0 and 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); 2. birth weight less than 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<0.40, 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: 1. gestational age (GA) more than 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); 2. birth weight more than 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<0.40, 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: 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. 8. parents reject to join

Gender:

All

Minimum Age:

N/A

Maximum Age:

12 Hours

Healthy Volunteers:

No

Location
Facility: Status: Contact: Children's Hospital of Chongqing Medical University Shi Yuan, PhD,MD 13508300283 86 [email protected]
Location Countries

China

Verification Date

2021-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Children's Hospital of Chongqing Medical University

Investigator Full Name: Chen Long,MD

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Selective HFOV

Type: Experimental

Description: Selective HFOV will be provided

Label: CMV

Type: Active Comparator

Description: CMV will be provided

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Neonates will be randomized and assigned either to selective HFOV or CMV

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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