Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome (NCT04113434) | Clinical Trial Compass
CompletedNot Applicable
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
United States513 participantsStarted 2020-01-07
Plain-language 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.
Who can participate
Age range44 Weeks – 17 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
28 Day Mortality in Pediatric ARDS.
Timeframe: 28 days
2
Presence of Two or More Endotypes in Pediatric ARDS.
Timeframe: Within 24 hours of ARDS onset
3
Occurrence of de Novo Sub-phenotypes in Pediatric ARDS Using Biomarkers and Whole Genome Transcriptomics of Peripheral Blood.