Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
NCT ID: NCT04113434
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2020-01-07
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. age \> 44 weeks corrected gestational age and \< 17.5 years
3. invasive mechanical ventilation via endotracheal tube
4. bilateral infiltrates on chest radiograph
5. oxygenation index (OI) ≥ 4; or oxygen saturation index (OSI) ≥ 5 on 2 consecutive measurements at least 4 hours apart but \< 24 hours apart
6. invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation criteria
Exclusion Criteria
2. cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA))
3. tracheostomy at time of screening
4. invasively ventilated for \> 7 days when meet ARDS criteria above
5. cardiac failure as predominant cause of respiratory failure
6. primary obstructive airway disease (asthma, bronchiolitis) by judgement of clinician as the primary cause of respiratory failure
7. alternative known chronic lung disease as cause of respiratory failure (cystic fibrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis, cryptogenic organizing pneumonia)
8. severe neurologic morbidity not expected to survive \> 72 hours
9. any limitations of care at time of screening
10. previous enrollment in this study
44 Weeks
17 Years
ALL
No
Sponsors
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Akron Children's Hospital
OTHER
Children's Hospital and Health System Foundation, Wisconsin
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Children's Mercy Hospital Kansas City
OTHER
Milton S. Hershey Medical Center
OTHER
Nationwide Children's Hospital
OTHER
Nicklaus Children's Hospital
UNKNOWN
Indiana University
OTHER
Cooperman Barnabas Medical Center
UNKNOWN
Baylor College of Medicine
OTHER
Columbia University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Arkansas Children's Hospital Research Institute
OTHER
Children's Healthcare of Atlanta
OTHER
Children's Hospital Colorado
OTHER
Washington University School of Medicine
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Nadir Yehya, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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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
Countries
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References
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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.
Other Identifiers
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19-016271
Identifier Type: -
Identifier Source: org_study_id
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