Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

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

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