Clinical Trial

Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome

Study acronym: DiNO
Recruiting
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Summary
The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[AVDSf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS). The study aims are: 1. To validate AVDSf for risk stratification of mortality in pediatric ARDS 2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf 3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.
Trial Details
NCT Number NCT06690801
Lead Sponsor Children's Hospital Los Angeles
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute Respiratory Distress Syndrome
Enrollment 1,260 participants
Start Date 2024-10-03
Primary Completion 2028-12-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-15