Actively Recruiting

Phase Not Applicable
Age: 1Minute - 1Hour
All Genders
NCT03736707

High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial

Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2025-10-06

400

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

D

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

Lead Sponsor

C

Children's Hospital of Chongqing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.

CONDITIONS

Official Title

High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial

Who Can Participate

Age: 1Minute - 1Hour
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age between 24 weeks 0 days and 31 weeks 6 days
  • Preterm infants admitted to NICU within 1 hour after birth with perinatal ARDS diagnosed by Montreux guidelines
  • Stable on conventional mechanical ventilation before randomization with specific respiratory and blood gas parameters
  • Hematocrit level above 35%
Not Eligible

You will not qualify if you...

  • Parents or guardians decline participation
  • Major congenital anomalies or chromosomal abnormalities
  • Need for surgery or grade higher than 2nd intraventricular hemorrhage before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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