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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2024
  • participants needed
    500
  • sponsor
    Children's Hospital of Philadelphia
Updated on 7 October 2022
mechanical ventilation
chest radiograph
acute respiratory distress
respiratory failure
oximetry
assisted breathing
assisted ventilation

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.

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. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latent class analysis, 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-day mortality), and explicitly tested for variation in response to exogenous treatments (e.g., corticosteroids).

Details
Condition Acute Respiratory Distress Syndrome
Clinical Study IdentifierNCT04113434
SponsorChildren's Hospital of Philadelphia
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
invasive blood drawing access (central venous catheter, arterial catheter, or blood-drawing IV)

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)
severe neurologic morbidity not expected to survive > 72 hours
any limitations of care at time of screening
previous enrollment in this study
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