Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome (LEOPARDS)
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|ClinicalTrials.gov Identifier: NCT04113434|
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease|
|Acute Respiratory Distress Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||December 2024|
- 28 Day Mortality in Pediatric ARDS. [ Time Frame: 28 days ]28 day all cause mortality.
- Presence of two or more endotypes in Pediatric ARDS. [ Time Frame: Within 24 hours of ARDS onset ]Stratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.
- Occurrence of de novo sub-phenotypes in pediatric ARDS using biomarkers and whole genome transcriptomics of peripheral blood. [ Time Frame: Within 24 hours of ARDS onset. ]Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.
- ventilator-free days at 28 days. [ Time Frame: 28 days ]composite endpoint of days alive and free of mechanical ventilation by day 28.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113434
|Contact: Nadir Yehya, M.D.||firstname.lastname@example.org|
|Contact: Stephen Famularo, BAemail@example.com|
|Principal Investigator:||Nadir Yehya, M.D.||Children's Hospital of Philadelphia|