Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07123961
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2026-01-01
• Primary Completion: 2029-12-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sustained Resolution of Hypoxemia	Up to 672 hours	The primary outcome of PARMA is time (in hours) per participant to sustained resolution of hypoxemia, defined as being alive with 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 two consecutive measurements 4 hours apart. This outcome is censored at 28 days (672 hours).

Secondary Outcome Measures

Name	Time	Method
Imaging (Electrical Impedance Tomography (EIT)): Overdistension	Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.	EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with overdistended lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined.
Imaging (Electrical Impedance Tomography (EIT)): Center of Ventilation	Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.	EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The average value of center of ventilation for each study arm at the immediate post-randomization EIT will be compared.
Clinical End Point: Pediatric ICU discharge	From enrollment up to pediatric ICU discharge, no longer than 90 days	Total days per participant until Pediatric ICU discharge from start of enrollment.
Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment	Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.	EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with recruited lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined.
Clinical End Point: all-cause mortality at 28 days	From enrollment up to hospital discharge, no longer than 28 days.	Total number of participants all-cause mortality at 28 days after enrollment or hospital discharge.
Clinical End Point: all-cause mortality at 90 days	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants all-cause mortality at 90 days after enrollment or hospital discharge.
Clinical End Point: Hospital Discharge	From enrollment up to hospital discharge, no longer than 90 days.	Total days per participant until hospital discharge from enrollment.
Clinical End Point: Primary Cause of Death	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants who meet primary cause of death as defined as brain death, other neurologic, multiple organ dysfunction syndrome, refractory shock, refractory hemorrhage or refractory hypoxemia.
Clinical End Point: Ventilator Free Days	From enrollment up to hospital discharge, no longer than 28 days.	Total ventilator free days (VFDs) per participant at 28 days (defined as number of days alive and off invasive ventilation by day 28).
Clinical End Point: New Oxygenation- or Ventilator-dependency	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants with new oxygenation- or ventilator-dependency at time of discharge.
Safety Endpoint: pneumothorax requiring chest tube	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants with diagnosis of pneumothorax requiring chest tube.
Safety Endpoint: other air leak not requiring chest tube	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants with diagnosis of other air leak not requiring chest tubes.
Safety Endpoint: ventilator-associated pneumonia	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants with diagnosis of ventilator-associated pneumonia.
Safety Endpoint: new or progressive multiple organ dysfunction syndrome	From enrollment up to hospital discharge, no longer than 90 days.	Total number of participants with diagnosis of new or progressive multiple organ dysfunction syndrome.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States