๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-11-13

Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome (NCT06690801)

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Children's Hospital Los Angeles

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Children's Hospital Los Angeles โ€” Los Angeles, California

Age range: 0 Years to 21 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • Children's Hospital Los Angeles โ€” Los Angeles, California
  • Children's Hospital Colorado โ€” Denver, Colorado
  • Boston Children's Hospital โ€” Boston, Massachusetts
  • University of Michigan / CS Mott Children's Hospital โ€” Ann Arbor, Michigan
  • University of Nebraska Medical Center / Children's Hospital and Medical Center โ€” Omaha, Nebraska
  • Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio
  • Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania
  • Texas Children's Hospital Baylor College of Medicine โ€” Houston, Texas
  • American Family Children's Hospital / University of Wisconsin-Madison โ€” Madison, Wisconsin
  • Children's Hospital of Wisconsin / Medical College of Wisconsin โ€” Milwaukee, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (323) 361-7939

Email: dinostudy@chla.usc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—