Status:
COMPLETED
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Akron Children's Hospital
Children's Hospital and Health System Foundation, Wisconsin
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
44-17 years
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 ther...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04113434
Start Date
January 7 2020
End Date
April 1 2025
Last Update
April 25 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Variety Children's Hospital D/B/A Nicklaus Children's Hospital
Miami, Florida, United States, 33155
4
Children's Healthcare of Atlanta - Emory
Atlanta, Georgia, United States, 30322