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.
Investigators will measure pre-determined biomarkers with known or suspected association with ARDS severity or outcome. Simultaneously, investigators will measure gene expression of peripheral blood. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latent class analysis, and hierarchical clustering with the goal of identifying sub-phenotypes of ARDS. These sub-phenotypes will be examined for association with outcome (primary is 28-day mortality), and explicitly tested for variation in response to exogenous treatments (e.g., corticosteroids).
Study Type
OBSERVATIONAL
Enrollment
500
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Colorado
Aurora, Colorado, United States
28 Day Mortality in Pediatric ARDS.
28 day all cause mortality.
Time frame: 28 days
Presence of two or more endotypes in Pediatric ARDS.
Stratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.
Time frame: Within 24 hours of ARDS onset
Occurrence of de novo sub-phenotypes in pediatric ARDS using biomarkers and whole genome transcriptomics of peripheral blood.
Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.
Time frame: Within 24 hours of ARDS onset.
ventilator-free days at 28 days.
composite endpoint of days alive and free of mechanical ventilation by day 28.
Time frame: 28 days
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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
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Indianapolis, Indiana, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
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Livingston, New Jersey, United States
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...and 6 more locations