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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).
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 7, 2020
Primary Completion Date
February 15, 2025
Completion Date
April 1, 2025
Last Updated
April 25, 2025
500
ACTUAL participants
Lead Sponsor
Children's Hospital of Philadelphia
Collaborators
NCT07450846
NCT07414056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06701669