Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to use a breathing machine (ventilator) to help children with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). ARDS makes it hard for the lungs to get enough oxygen into the blood. Right now, doctors use ventilator settings based on adult patients, but children’s lungs work differently, so this study aims to find out which ventilator method works best specifically for kids. The results will help improve treatment in the future and may lead to a larger study.

Children between 2 weeks and 18 years old who have trouble breathing suddenly and need a ventilator to help them breathe may be eligible for this study. To join, their lung problem must have started within the last week, and they must be using a breathing tube. The study will compare two ways of using the ventilator to see which helps children’s lungs work better. Participants will be closely monitored by doctors and nurses throughout the study. It’s important to know that children with certain heart problems, airway diseases, or those already very critically ill may not be able to join. This trial is not yet recruiting participants but is designed to improve care for children with this serious lung condition.

Gender

ALL

Eligibility 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