NCT03736707 High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial
| NCT ID | NCT03736707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-10-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT03736707 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 1 Hour, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03736707 currently recruiting?
Yes, NCT03736707 is actively recruiting participants. Visit ClinicalTrials.gov or contact Daping Hospital and the Research Institute of Surgery of the Third Military Medical University to inquire about joining.
Where is the NCT03736707 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT03736707 clinical trial?
NCT03736707 is sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. The trial plans to enroll 400 participants.