High-frequency oscillatory ventilation versus conventional mechanical ventilation for very preterm infants with perinatal ARDS

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 1 Minute to 1 Hour
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT03736707 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Chongqing, Chongqing Municipality

• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)

Conditions: Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation, Preterm, Conventional Mechanical Ventilation