Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome

Completed

Conditions studied: Acute Respiratory Distress Syndrome

In brief

The overall goal of the study is to risk stratify pediatric Acute Respiratory Distress Syndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order to appropriately target therapies in future trials. This is a prospective, multicenter study of 500 intubated children with ARDS, with planned blood collection within 24 hours of ARDS onset and subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.

Key facts

Study ID

NCT04113434

Run by

Children's Hospital of Philadelphia

People needed

513

Starts

2020-01-07

Expected to finish

2025-04-01

Last updated by the study team

2026-04-20

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
• age > 44 weeks corrected gestational age and < 17.5 years
• invasive mechanical ventilation via endotracheal tube
• bilateral infiltrates on chest radiograph
• oxygenation index (OI) ≥ 4; or oxygen saturation index (OSI) ≥ 5 on 2 consecutive measurements at least 4 hours apart but < 24 hours apart
• invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation criteria

You may not qualify if…

• weight < 3 kilograms
• cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA))
• tracheostomy at time of screening
• invasively ventilated for > 7 days when meet ARDS criteria above
• cardiac failure as predominant cause of respiratory failure
• primary obstructive airway disease (asthma, bronchiolitis) by judgement of clinician as the primary cause of respiratory failure
• alternative known chronic lung disease as cause of respiratory failure (cystic fibrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis, cryptogenic organizing pneumonia)
• severe neurologic morbidity not expected to survive > 72 hours
• any limitations of care at time of screening
• previous enrollment in this study

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Variety Children's Hospital D/B/A Nicklaus Children's Hospital — Miami, Florida, United States
• Children's Healthcare of Atlanta - Emory — Atlanta, Georgia, United States
• Riley Children's at Indiana University Health — Indianapolis, Indiana, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital / Baylor College of Medicine — Houston, Texas, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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