Combined Oscillation-Volume guarantEe Study

Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)

NCT07377955•Xingwang Zhu

View on ClinicalTrials.gov

Summary

Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes. HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma. This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Gestational age 24+0/7\< 320/7 weeks
•Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV

Exclusion Criteria

•Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
•Uncorrected shock
•Existence of grade 3-4 IVH before ventilated
•Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2028

Last Updated

January 30, 2026

Enrollment

348

ESTIMATED participants

Conditions

Respiratory Distress Syndrome (& [Hyaline Membrane Disease])Bronchopulmonary Dysplasia (BPD)

Interventions

HFOV

DEVICE

HFOV+VG

DEVICE

Contacts

Yuan Shi, PhD

CONTACT

+86 23 68757731 shiyuan@hospital.cqmu.edu.cn

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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: January 30, 2026Data 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.

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