Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-17
SponsorChildren's Hospital of Philadelphia

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • High Driving Pressure Mechanical Ventilation
  • Low Driving Pressure Mechanical Ventilation

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

University of Pennsylvania

Collaborator