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Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS) | Clinical Trials | Clareo Health

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

Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial

NCT03591796•Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

December 31, 2024

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

July 9, 2025

Enrollment

386

ACTUAL participants

Conditions

Acute Respiratory Distress SyndromeConventional Mechanical VentilationHigh Frequency Oscillation Ventilation

Interventions

HFOV

DEVICE

CMV

DEVICE

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Acute Respiratory Distress SyndromeRight Heart Failure

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RECRUITING

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NCT07414056

Acute Respiratory Distress Syndrome (ARDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Assessment of Airway Opening Pressure in Invasively Ventilated Children

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

Free for Weaning ECMO vs Respiratory Driven Study