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RECRUITING
NCT06690801

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

Sponsor: Children's Hospital Los Angeles

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Years - 21 Years

Study Type

OBSERVATIONAL

Enrollment

1260

Start Date

2024-10-03

Completion Date

2029-02-01

Last Updated

2024-11-15

Healthy Volunteers

No

Locations (10)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Denver, Colorado, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan / CS Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Nebraska Medical Center / Children's Hospital and Medical Center

Omaha, Nebraska, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital Baylor College of Medicine

Houston, Texas, United States

American Family Children's Hospital / University of Wisconsin-Madison

Madison, Wisconsin, United States

Children's Hospital of Wisconsin / Medical College of Wisconsin

Milwaukee, Wisconsin, United States