Pediatric ARDS ventilator strategy comparison
Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial
This study will test two different ventilator pressure strategies to see which helps children (ages >2 weeks to under 18 years) with ARDS breathe and recover better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 2 Weeks to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07123961 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares a higher versus a lower driving‑pressure mechanical ventilation approach in children with acute respiratory distress syndrome. Eligible participants are infants older than 2 weeks (corrected gestational age >38 weeks) through adolescents under 18 who require invasive mechanical ventilation within seven days of ARDS onset, have bilateral chest radiograph opacities, and meet specified hypoxemia criteria. Enrolled patients will be assigned to one of the two ventilator strategies while clinicians monitor oxygenation, lung mechanics, duration of ventilation, and clinical outcomes. Results are intended to identify the more beneficial ventilator approach in children and to inform the design of a larger definitive trial.
Who should consider this trial
Good fit: Children older than 2 weeks (corrected gestational age >38 weeks) up to 17 years who are invasively ventilated within seven days of ARDS onset, have bilateral lung opacities, and meet the study oxygenation criteria are the intended candidates.
Not a fit: Patients whose hypoxemia is primarily due to hydrostatic pulmonary edema from heart failure or fluid overload, and those with protocol‑excluded unrepaired or non‑palliated conditions, are unlikely to benefit from the ventilation strategies tested.
Why it matters
Potential benefit: If successful, this could identify ventilator settings that reduce lung injury, shorten time on the ventilator, and improve recovery for children with ARDS.
How similar studies have performed: Adult ARDS trials have shown benefits from lung‑protective and lower driving‑pressure ventilation, but pediatric-specific evidence is limited and direct comparisons in children are uncommon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: 1. age \> 2 weeks (\> 38 weeks corrected gestational age) and \< 18 years (not yet had 18th birthday) 2. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation 3. ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset 4. hypoxemia defined as PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) \> 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) \> 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O (rate of pressure delivery) on two consecutive measurements 4 hours apart and sustained at the time of consent and randomization 5. bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI Exclusion: 1. hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload 2. non-palliated or unrepaired cyanotic congenital heart disease 3. ventilated via tracheostomy at baseline prior to acute illness 4. obstructive airway disease determined to be the primary cause of respiratory failure 5. severe moribund state not expected to survive \> 72 hours 6. any limitations of care at time of screening 7. escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening 8. previous enrollment in this study
Where this trial is running
Philadelphia, Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Nadir Yehya, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Helena Wiatrowski, B.A.
- Email: wiatrowskh@chop.edu
- Phone: 7818123947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.