Clinical trial NCT03591796: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Conventional Mechanical Ventilation
High Frequency Oscillation Ventilation
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
name: Jiulongpo No.1 People's Hospital
name: Chongqing Maternal and Child Health Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Children's Hospital of The Capital Institute of Pediatrics
name: Peking University Third Hospital
name: First Hospital of Tsinghua University
name: Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Quanzhou Children's Hospital
name: Xiamen Maternity & Child Care Hospital
name: Zhujiang Hospital
name: Guangdong Academy of Medical Science and General Hospital
name: Guangdong Women and Children Hospital
name: Women and Children's Health Hospital of Yulin
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Second Affiliated Hospital of Guangzhou Medical University
name: Guiyang Maternal and Child Health Care Hospital
name: The First People's Hospital of Zunyi
name: Lanzhou University Second Hospital
name: Gansu Provincial Maternal and Child Health Care Hospital
name: LanZhou University
name: First Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: Zhengzhou Children's Hospital, China
name: Third Affiliated Hospital of Zhengzhou University
name: the Maternal and Child Health Hospital of Hainan Province
name: Bethune International Peace Hospital
name: Wuhan Union Hospital, China
name: Children's Hospital of Nanjing Medical University
name: The First Hospital of Jilin University
name: Children's Hospital of Fudan University
name: Maternal and Children's Healthcare Hospital of Taian
name: The Second Hospital of Shandong University
name: Shanxi Provincial Maternity and Children's Hospital
name: Chengdu Women and Children's Center Hospital
name: The Affiliated Hospital Of Southwest Medical University
name: Affiliated Hospital of Southwest Medical University
name: Shenzhen People's Hospital, The Second Medical College of Jinan University
name: Tianjin Central Hospital of Gynecology Obstetrics
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Kunming Children's Hospital
name: The First People's Hospital of Yunnan
name: First Affiliated Hospital of Kunming Medical University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: Women and Children's Health Hospital of Qujing
name: The People's Hospital of Dehong Autonomous Prefecture
name: The First People's Hospital of Yinchuan
name: The Children's Hospital of Zhejiang University School of Medicine
name: Women's Hospital School Of Medicine Zhejiang University
name: Beijing 302 Hospital
name: Hunan Children's Hospital
name: Women and Children Hospital of Qinghai Province
name: Jiangxi Province Children's Hospital
name: Inner Mongolia People's Hospital
name: Mianyang Central Hospital
name: People's Liberation Army No.202 Hospital
name: Ningbo Women & Children's Hospital
name: Shanghai Children's Medical Center
name: First Affiliated Hospital of Guangxi Medical University
name: Nanjing Medical University
name: Qinhuangdao Maternal and Child Health Care Hospital
name: Xuzhou Children Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Xianyang Children's Hospital
First posted: 2018-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the incidence of bronchopulmonary dysplasia (BPD)
timeFrame: 28 days after birth or 36 weeks'gestational age
measure: Death
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
Secondary outcomes:
measure: the incidence of neonatal necrotizing enterocolitis(NEC)
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
measure: the incidence of retinopathy of prematurity(ROP)
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
measure: Intraventricular hemorrhage
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
measure: composite mortality/BPD
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
measure: the incidence of airleak
timeFrame: 28 days after birth or 36 weeks'gestational age or before discharge
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: