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

NCT ID: NCT03591796

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome Conventional Mechanical Ventilation High Frequency Oscillation Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HFOV

Ventilated infants were randomized to HFOV.

Group Type EXPERIMENTAL

HFOV

Intervention Type DEVICE

Ventilated infants were randomized to HFOV

CMV

Ventilated infants were randomized to CMV.

Group Type ACTIVE_COMPARATOR

CMV

Intervention Type DEVICE

Ventilated infants were randomized to CMV.

Interventions

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HFOV

Ventilated infants were randomized to HFOV

Intervention Type DEVICE

CMV

Ventilated infants were randomized to CMV.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Gestational age (GA) between 25+0 and 34+0 weeks;
* Assisted with CMV within 12 h after birth;
* Diagnosis with ARDS;
* Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \> 7.20, PaCO2 60 mmHg and \> 35% of hematocrit

Exclusion Criteria

* parents' decision not to participate;
* Major congenital anomalies or chromosomal abnormalities;
* Upper respiratory tract abnormalities;
* need for surgery before randomization;
* Grade Ⅲ-IV-intraventricular hemorrhage (IVH).
Minimum Eligible Age

1 Minute

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Jiulongpo No.1 People's Hospital

OTHER

Sponsor Role collaborator

Chongqing Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Children's Hospital of The Capital Institute of Pediatrics

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

First Hospital of Tsinghua University

OTHER

Sponsor Role collaborator

Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Quanzhou Children's Hospital

OTHER

Sponsor Role collaborator

Xiamen Maternity & Child Care Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Guangdong Academy of Medical Science and General Hospital

OTHER

Sponsor Role collaborator

Guangdong Women and Children Hospital

OTHER

Sponsor Role collaborator

Women and Children's Health Hospital of Yulin

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Guiyang Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Zunyi

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

the Maternal and Child Health Hospital of Hainan Province

OTHER

Sponsor Role collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Children's Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Maternal and Children's Healthcare Hospital of Taian

OTHER

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

Chengdu Women and Children's Center Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Southwest Medical University

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital, The Second Medical College of Jinan University

OTHER

Sponsor Role collaborator

Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

Kunming Children's Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Women and Children's Health Hospital of Qujing

OTHER

Sponsor Role collaborator

The People's Hospital of Dehong Autonomous Prefecture

OTHER

Sponsor Role collaborator

The First People's Hospital of Yinchuan

OTHER

Sponsor Role collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Women and Children Hospital of Qinghai Province

OTHER

Sponsor Role collaborator

Jiangxi Province Children's Hospital

OTHER

Sponsor Role collaborator

Inner Mongolia People's Hospital

OTHER

Sponsor Role collaborator

Mianyang Central Hospital

OTHER

Sponsor Role collaborator

People's Liberation Army No.202 Hospital

OTHER

Sponsor Role collaborator

Ningbo Women & Children's Hospital

OTHER

Sponsor Role collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Qinhuangdao Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Xuzhou Children Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Xianyang Children's Hospital

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Chen Long,MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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invasive ventilation for ARDS

Identifier Type: -

Identifier Source: org_study_id

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