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

Children's Hospital of Philadelphia (CHOP)

Status and phase: Enrolling; Phase 2

Conditions: Pediatric Acute Respiratory Distress Syndrome (PARDS); Acute Respiratory Distress Syndrome (ARDS); Ventilator Management; Lung-protective Ventilation

Treatments: Other: High Driving Pressure Mechanical Ventilation; Other: Low Driving Pressure Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07123961

24-022470

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 38 weeks to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

High Driving Pressure Mechanical Ventilation

Active Comparator group

Description:

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.

Treatment:

Other: High Driving Pressure Mechanical Ventilation

Low Driving Pressure Mechanical Ventilation

Active Comparator group

Description:

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.

Treatment:

Other: Low Driving Pressure Mechanical Ventilation