Actively Recruiting
Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial
Led by Children's Hospital of Philadelphia · Updated on 2026-03-16
160
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute respiratory distress syndrome (ARDS) in children is a serious lung condition that can be life-threatening. Current ventilator settings are often based on adult treatments, but children's bodies respond differently, so it is important to find the best ventilator approach for pediatric patients. This trial compares two ventilator strategies to see which one might provide better support for children with ARDS and will help guide future larger studies. Children already on a breathing machine will be randomly assigned to receive one of two pressure settings: a high driving pressure set to 25 cmH2O or a low driving pressure set to 15 cmH2O using a specific ventilator model (Evita V500). All other clinical care, including sedation and fluid management, will follow standard practices. Lung imaging using Electrical Impedance Tomography (EIT) will be done up to four times during the study to observe lung aeration. Participants will be monitored for up to 672 hours to assess sustained improvement in oxygen levels. Additional assessments include lung imaging at several time points after randomization and clinical outcomes such as mortality, ICU and hospital discharge, ventilator-free days, and safety events like pneumothorax or pneumonia. The study follow-up lasts up to 90 days to track these outcomes and safety endpoints.
CONDITIONS
Brief Title
Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 2 weeks (more than 38 weeks corrected gestational age) and under 18 years (not yet 18th birthday)
- Acute respiratory failure starting within 7 days requiring invasive mechanical ventilation
- Ventilated with endotracheal tube or tracheostomy for 7 days or less from risk factor onset
- Hypoxemia with specific oxygenation measurements sustained at consent and randomization
- Bilateral opacities on chest X-ray confirmed by radiologist or clinical team
You will not qualify if you...
- Hypoxemia mainly caused by heart failure or fluid overload
- Unrepaired or non-palliated cyanotic congenital heart disease
- Ventilated via tracheostomy before current acute illness
- Obstructive airway disease as main cause of respiratory failure
- Expected to survive less than 72 hours due to severe moribund state
- Any limitations on care at screening time
- Already escalated to high frequency oscillatory ventilation or extracorporeal support at screening
- Previous participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until resolution of respiratory failure
Participants receive mechanical ventilation with either high or low driving pressure settings while standard clinical care continues. They will have an Electrical Impedance Tomography (EIT) device strap placed on their chest up to four times during the study to image lung aeration.
Multiple visits during mechanical ventilation
Duration - Up to 90 days
Participants are monitored for clinical outcomes including survival, ventilator-free days, and adverse events up to hospital discharge or 90 days after enrollment.
Periodic follow-up visits until hospital discharge or 90 days
Trial Site Locations
Total: 1 location
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
H
Helena Wiatrowski, B.A.
S
Stephen Famularo III, B.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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