Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03591796
• Other study ID #: invasive ventilation for ARDS
• Status: Withdrawn
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 12 Hours

Eligibility

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 ?-IV-intraventricular hemorrhage (IVH);

• Congenital lung diseases or malformations or pulmonary hypoplasia.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Conventional Mechanical Ventilation
• High Frequency Oscillation Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• HFOV
Ventilated infants were randomized to HFOV
• CMV
Ventilated infants were randomized to CMV.

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (66)

Lead Sponsor

Collaborator

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

Affiliated Hospital of Southwest Medical University, Beijing 302 Hospital, Bethune International Peace Hospital, Chengdu Women and Children's Center Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, Children's Hospital of Nanjing Medical University, Children's Hospital of The Capital Institute of Pediatrics, Chongqing Maternal and Child Health Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Tsinghua University, Gansu Provincial Maternal and Child Health Care Hospital, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Guiyang Maternal and Child Health Care Hospital, Hunan Children's Hospital, Inner Mongolia People's Hospital, Jiangxi Province Children's Hospital, Jiulongpo No.1 People's Hospital, Kunming Children's Hospital, LanZhou University, Maternal and Children's Healthcare Hospital of Taian, Mianyang Central Hospital, Nanjing Medical University, Ningbo Women & Children's Hospital, Peking University Third Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, People's Liberation Army No.202 Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Quanzhou Children's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Hospital of Lanzhou University, Shanghai Children's Medical Center, Shanxi Provincial Maternity and Children's Hospital, Shenzhen People's Hospital, The Second Medical College of Jinan University, The Affiliated Hospital Of Southwest Medical University, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, The First People's Hospital of Yunnan, The First People's Hospital of Zunyi, the Maternal and Child Health Hospital of Hainan Province, The People's Hospital of Dehong Autonomous Prefecture, The Second Hospital of Shandong University, Third Affiliated Hospital of Zhengzhou University, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous, Women and Children Hospital of Qinghai Province, Women and Children's Health Hospital of Qujing, Women and Children's Health Hospital of Yulin, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, Women's Hospital School Of Medicine Zhejiang University, Wuhan Union Hospital, China, Xiamen Maternity & Child Care Hospital, Xianyang Children's Hospital, Xuzhou Children Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University, Zhengzhou Children's Hospital, China, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of bronchopulmonary dysplasia (BPD)	the included neonate was diagnosed with BPD	28 days after birth or 36 weeks'gestational age
Primary	Death	the included preterm infants were dead	28 days after birth or 36 weeks'gestational age or before discharge
Secondary	the incidence of neonatal necrotizing enterocolitis(NEC)	the included neonate was diagnosed with NEC	28 days after birth or 36 weeks'gestational age or before discharge
Secondary	the incidence of retinopathy of prematurity(ROP)	the included neonate was diagnosed with ROP	28 days after birth or 36 weeks'gestational age or before discharge
Secondary	Intraventricular hemorrhage	Intraventricular hemorrhage was diagnosed	28 days after birth or 36 weeks'gestational age or before discharge
Secondary	composite mortality/BPD	composite mortality/BPD was diagnosed	28 days after birth or 36 weeks'gestational age or before discharge
Secondary	the incidence of airleak	the included neonate was diagnosed with airleak	28 days after birth or 36 weeks'gestational age or before discharge