N/A
Completed N=513
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Source: ClinicalTrials.gov NCT04113434 ↗Enrolled (actual)
513
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: 28 Day Mortality in Pediatric ARDS. — 44 Participants — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 28 Day Mortality in Pediatric ARDS. |
44 | <0.05 sig |
| PRIMARY Presence of Two or More Endotypes in Pediatric ARDS. |
70 | <0.05 sig |
| PRIMARY Occurrence of de Novo Sub-phenotypes in Pediatric ARDS Using Biomarkers and Whole Genome Transcriptomics of Peripheral Blood. |
70 | — |
| SECONDARY Ventilator-free Days at 28 Days. |
20 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
- age > 44 weeks corrected gestational age and 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
Data sourced from ClinicalTrials.gov (NCT04113434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.