Actively Recruiting

Phase 2
Age: 2Weeks - 17Years
All Genders
NCT07123961

Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Led by Children's Hospital of Philadelphia · Updated on 2026-03-16

160

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Who Can Participate

Age: 2Weeks - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 2 weeks (more than 38 weeks corrected gestational age) and less than 18 years (not yet had 18th birthday)
  • Acute respiratory failure requiring invasive mechanical ventilation within 7 days of risk factor onset
  • Ventilated with endotracheal tube or tracheostomy for 7 days or less from risk factor onset
  • Hypoxemia defined as PaO2/FIO2 > 300 or SpO2/FIO2 > 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O on two consecutive measurements 4 hours apart and sustained at consent and randomization
  • Bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or principal investigator
Not Eligible

You will not qualify if you...

  • Hypoxemia primarily caused 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 as the primary cause of respiratory failure
  • Severe moribund state not expected to survive more than 72 hours
  • Any limitations of care at time of screening
  • Escalation to high frequency oscillatory ventilation or extracorporeal support at time of screening
  • Previous enrollment in this study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

H

Helena Wiatrowski, B.A.

CONTACT

S

Stephen Famularo III, B.A.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial | DecenTrialz