Actively Recruiting
Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial
Led by Children's Hospital of Philadelphia · Updated on 2026-03-16
160
Participants Needed
1
Research Sites
242 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) is a serious and potentially life-threatening lung condition that can affect children. Currently, ventilator settings commonly used in treatment are based on approaches developed for adults, and it remains unclear whether these settings are equally effective for children. Because children's bodies respond differently than adults', it is important to determine the most effective ventilator strategies specifically for pediatric patients. This study will compare two different ventilator approaches in children with ARDS to identify which method provides the greatest benefit. The findings will also help inform the design of a larger study in the future.
CONDITIONS
Official Title
Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 2 weeks (more than 38 weeks corrected gestational age) and less than 18 years (not yet had 18th birthday)
- Acute respiratory failure requiring invasive mechanical ventilation within 7 days of risk factor onset
- Ventilated with endotracheal tube or tracheostomy for 7 days or less from risk factor onset
- Hypoxemia defined as PaO2/FIO2 > 300 or SpO2/FIO2 > 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O on two consecutive measurements 4 hours apart and sustained at consent and randomization
- Bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or principal investigator
You will not qualify if you...
- Hypoxemia primarily caused by hydrostatic pulmonary edema from heart failure or fluid overload
- Non-palliated or unrepaired cyanotic congenital heart disease
- Ventilated via tracheostomy at baseline prior to acute illness
- Obstructive airway disease as the primary cause of respiratory failure
- Severe moribund state not expected to survive more than 72 hours
- Any limitations of care at time of screening
- Escalation to high frequency oscillatory ventilation or extracorporeal support at time of screening
- Previous enrollment in this study
AI-Screening
AI-Powered Screening
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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.
CONTACT
S
Stephen Famularo III, B.A.
CONTACT
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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