Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 17
Healthy Volunteers: f
View:

• age \> 2 weeks (\> 38 weeks corrected gestational age) and \< 18 years (not yet had 18th birthday)

• acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation

• ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset

• 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

• bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI

Locations
United States
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Helena Wiatrowski, B.A.
wiatrowskh@chop.edu
7818123947
Backup
Stephen Famularo III, B.A.
famularois@chop.edu
412-478-7643
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 160
Treatments
Active_comparator: High Driving Pressure Mechanical Ventilation
A participant who is already on the breathing machine will have the driving pressure set to 25 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.
Active_comparator: Low Driving Pressure Mechanical Ventilation
A participant who is already on the breathing machine will have the driving pressure set to 15 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: University of Pennsylvania

This content was sourced from clinicaltrials.gov