Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome (LEOPARDS)

C
Courtney Rowan, MD

Primary Investigator

Administratively Closed
44 weeks - 17 years
All
Phase N/A
500 participants needed
1 Location

Brief description of study

The overall goal of the study is to risk stratify pediatric Acute Respiratory Distressyndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order toy 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 onsetd subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.

Detailed description of study

Investigators will measure pre-determined biomarkers with known or suspected association with ARDS severity or outcome. Simultaneously, investigators will measure gene expression ofheral blood. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latentysis, and hierarchical clustering with the goal of identifying sub-phenotypes of ARDS. These sub-phenotypes will be examined for association with outcome (primary is 28-dayy), and explicitly tested for variation in response to exogenous treatments (e.g.,ds).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Respiratory Distress Syndrome, Riley
  • Age: 44 weeks - 17 years
  • Gender: All

Inclusion Criteria:
  1. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanicalventilation
  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 consecutiveurements at least 4 hours apart but < 24 hours apart
  6. invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation
Exclusion Criteria:
  1. weight < 3 kilograms
  2. cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or PatentDuctus 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 clinicianhe primary cause of respiratory failure
  7. alternative known chronic lung disease as cause of respiratory failure (cysticbrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis,yptogenic 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

Updated on 19 May 2025. Study ID: PICU-CHOP-LEOPARDS, 1909158033

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