RecruitingPhase 2NCT07123961

Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

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

Sponsor

Children's Hospital of Philadelphia

Enrollment

160 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Distress Syndrome (ARDS)Ventilator Management

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

Min Age: 2 WeeksMax Age: 17 Years

Inclusion Criteria5

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

Exclusion Criteria8

hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
non-palliated or unrepaired cyanotic congenital heart disease
ventilated via tracheostomy at baseline prior to acute illness
obstructive airway disease determined to be the primary cause of respiratory failure
severe moribund state not expected to survive \> 72 hours
any limitations of care at time of screening
escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening
previous enrollment in this study

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Interventions

OTHERHigh Driving Pressure Mechanical Ventilation

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.

OTHERLow Driving Pressure Mechanical Ventilation

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.