Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
LEOPARDS
2 other identifiers
observational
513
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedStudy Start
First participant enrolled
January 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedResults Posted
Study results publicly available
April 20, 2026
CompletedApril 20, 2026
April 1, 2026
5.1 years
October 1, 2019
February 9, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
28 Day Mortality in Pediatric ARDS.
28 day all cause mortality.
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.
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.
Within 24 hours of ARDS onset.
Secondary Outcomes (1)
Ventilator-free Days at 28 Days.
28 days
Eligibility Criteria
Infants to adolescents between the ages of 44 weeks and 17.5 years, who are admitted to PICU for acute respiratory failure requiring invasive mechanical ventilation.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Akron Children's Hospitalcollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Children's Mercy Hospital Kansas Citycollaborator
- Milton S. Hershey Medical Centercollaborator
- Nationwide Children's Hospitalcollaborator
- Nicklaus Children's Hospitalcollaborator
- Indiana Universitycollaborator
- Cooperman Barnabas Medical Centercollaborator
- Baylor College of Medicinecollaborator
- Columbia Universitycollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Arkansas Children's Hospital Research Institutecollaborator
- Children's Healthcare of Atlantacollaborator
- Children's Hospital Coloradocollaborator
- Washington University School of Medicinecollaborator
- Children's Hospital and Health System Foundation, Wisconsincollaborator
Study Sites (16)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Variety Children's Hospital D/B/A Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Children's Healthcare of Atlanta - Emory
Atlanta, Georgia, 30322, United States
Riley Children's at Indiana University Health
Indianapolis, Indiana, 46202, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University
St Louis, Missouri, 63110, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Columbia University Medical Center
New York, New York, 10032, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Whitney JE, Johnson GM, Varisco BM, Raby BA, Yehya N. Biomarker-Based Risk Stratification Tool in Pediatric Acute Respiratory Distress Syndrome: Single-Center, Longitudinal Validation in a 2014-2019 Cohort. Pediatr Crit Care Med. 2024 Jul 1;25(7):599-608. doi: 10.1097/PCC.0000000000003512. Epub 2024 Apr 9.
PMID: 38591949DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nadir Yehya
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
Nadir Yehya, M.D.
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 2, 2019
Study Start
January 7, 2020
Primary Completion
February 15, 2025
Study Completion
April 1, 2025
Last Updated
April 20, 2026
Results First Posted
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Gene expression data will be released to Gene Expression Omnibus simultaneously with the publication of the data. Biomarker data will be released within 2 years of publication of the main manuscript.
- Access Criteria
- We will follow NHLBI's guidelines for accessing BioLINCC data.
Specific consent will be obtained to store blood and use data for future research. We will share data with the research community using the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) program at NHLBI, and we will follow suggested guidelines for de-identifying the data (coding of site IDs, conversion of dates to study days). Pursuant to the NIH policy, all data obtained from this proposal will be made available for research by qualified individuals within the scientific community after publication of the proposed studies. Gene expression data from Aims 2 and 3 will be made available simultaneous with publication of the results of these aims by uploading to the Gene Expression Omnibus. For dissemination of plasma biomarker results and the associated clinical dataset, we will use BioLINCC program at NHLBI, with release of a de-identified dataset with untraceable identifiers within 2 years of publication of the main manuscript.