Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

NCT07123961 | Recruiting Phase 2 DMC

• 1 other identifier: 24-022470
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Acute Respiratory Distress Syndrome; ARDS; Vent; Ventilator; Ventilator Management; Pediatric ARDS; Pediatric Ventilator Management; PARDS; Pediatric ARDS Protocolized Treatment; Invasive Mechanical Ventilation; IMV; Pediatric Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Sustained Resolution of Hypoxemia

  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).

  Up to 672 hours

Secondary Outcomes (14)

• 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.

• 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.

• 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.

• Clinical End Point: all-cause mortality at 90 days

  From enrollment up to hospital discharge, no longer than 90 days.

• Clinical End Point: all-cause mortality at 28 days

  From enrollment up to hospital discharge, no longer than 28 days.

Study Arms (2)

High Driving Pressure Mechanical Ventilation

ACTIVE COMPARATOR

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.

Other: High Driving Pressure Mechanical Ventilation

Low Driving Pressure Mechanical Ventilation

ACTIVE COMPARATOR

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.

Other: Low Driving Pressure Mechanical Ventilation

Interventions

High Driving Pressure Mechanical Ventilation OTHER

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.

High Driving Pressure Mechanical Ventilation

Low Driving Pressure Mechanical Ventilation OTHER

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.

Low Driving Pressure Mechanical Ventilation

Eligibility Criteria

• Age: 2 Weeks - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Nadir Yehya, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Wiatrowski, B.A.

CONTACT

7818123947; wiatrowskh@chop.edu

Stephen Famularo III, B.A.

CONTACT

412-478-7643; famularois@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible and consented subjects will be randomized within 24 hours of meeting study eligibility using 1:1 permuted blocks, using a randomization module available in Research Electronic Data CAPture (REDCap).

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 14, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data (IPD) will be shared 1 year after main manuscript publication.
• Access Criteria: The IPD will be made readily available for research by qualified individuals within the scientific community as determined by DASH's regulatory and contractual requirements. The dataset will be accessible via the DASH platform.

Locations

US (1)