High-frequency oscillatory ventilation versus conventional mechanical ventilation for very preterm infants with perinatal ARDS
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
Run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · NCT03736707 · Data updated 2026-11-12
This trial will test whether high-frequency oscillatory ventilation helps very preterm infants with perinatal ARDS breathe better and reduce lung complications compared with standard mechanical ventilation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Minute to 1 Hour |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT03736707 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Very preterm neonates born at 24+0 to 31+6 weeks, admitted to a participating NICU within one hour of birth, diagnosed with perinatal ARDS by Montreux guidelines and stabilized on CMV under the trial's preset parameters are eligible.
✕Probably not a fit
Infants with major congenital or chromosomal anomalies, those needing immediate surgery or with more than grade 2 intraventricular hemorrhage before randomization, and those whose guardians decline participation are not expected to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter randomized controlled superiority trial comparing high-frequency oscillatory ventilation (HFOV) to conventional mechanical ventilation (CMV) in very preterm infants born between 24+0 and 31+6 weeks with perinatal ARDS. Eligible infants are admitted within one hour of birth, diagnosed by the Montreux criteria, stabilized on CMV for two hours under specified settings, then randomized to HFOV or continued CMV. The trial tracks respiratory outcomes including bronchopulmonary dysplasia incidence, duration of invasive ventilation, gas exchange, and ventilator-related complications during the NICU course. The study is led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University with participating neonatal centers in Chongqing, China.
Why it matters
Potential benefit: If successful, HFOV could lower the risk of bronchopulmonary dysplasia and shorten the time very preterm infants need invasive ventilation.
How similar studies have gone: Animal studies and some small human reports have suggested possible benefits of HFOV, but randomized trials in humans have produced inconsistent results and the approach is not yet definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria 1. GA was between 24+0 and 31+6 weeks. 2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV. 3. 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, tidal volume of 5 ml/kg and \> 35% of hematocrit (these may be evaluated by arterial blood gas analysis). Exclusion criteria Neonates were not included if any of the following criteria were met: 1. Parents or guardians' decision not to participate. 2. Major congenital anomalies or chromosomal abnormalities 3. Need for surgery or more than grade 2nd of IVH before randomization.
Where it's running
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.