Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07123961
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Respiratory Distress Syndrome (ARDS)
  • Lung-protective Ventilation
  • Pediatric Acute Respiratory Distress Syndrome (PARDS)
  • Ventilator Management

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • High Driving Pressure Mechanical Ventilation — OTHER
    A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Dräger, Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 25 cmH2O (rate of pressure delivery). The Children's Hospital of Philadelphia (CHOP) PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 Electrical Impedance Tomography (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.
  • Low Driving Pressure Mechanical Ventilation — OTHER
    A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 15 cmH2O (rate of pressure delivery). CHOP PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Sustained Resolution of Hypoxemia [ Time Frame: Up to 672 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Helena Wiatrowski, B.A.
[email protected]
781-812-3947
Stephen Famularo
[email protected]
Nadir Yehya, MD, MSCE (PRINCIPAL_INVESTIGATOR)

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