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Phase 4Recruiting

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Sponsored by The University of Texas Health Science Center, Houston

About this study

The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing iNO as a therapy in the postnatal resuscitation/stabilization phase of CDH management, which will be assessed as the incremental health system costs (savings) per prevented ECLS use and/or death.

In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.

Where this study is enrolling (19)

  • University of Alabama & Children's Hospital of Alabama (UAB-CoA)

    Birmingham, Alabama

    I'm interested

  • University of Arkansas & Arkansas Children's Hospital (UA-ACH)

    Little Rock, Arkansas

    I'm interested

  • University of California, San Diego & Rady Children's Hospital (UCSD-Rady)

    San Diego, California

    I'm interested

  • Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)

    Palo Alto, California

    I'm interested

  • University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)

    Irvine, California

    I'm interested
Show all 19 locations

  • University of Southern California & Children's Hospital Los Angeles (USC-CHLA)

    Los Angeles, California

    I'm interested

  • University of Colorado & Children's Hospital of Colorado (CU-CHC)

    Aurora, Colorado

    I'm interested

  • Emory University & Children's Healthcare of Atlanta (CHOA)

    Atlanta, Georgia

    I'm interested

  • Indiana University & Riley Children's Hospital (IU-RiCH)

    Indianapolis, Indiana

    I'm interested

  • University of Louisville & Norton Children's Hospital (UL-NCH)

    Louisville, Kentucky

    I'm interested

  • Harvard University & Boston Children's Hospital (Harvard-BCH)

    Boston, Massachusetts

    I'm interested

  • University of Michigan & CS Mott Children's Hospital (UM-CSMott)

    Ann Arbor, Michigan

    I'm interested

  • Randall Children's Hospital-Portland (RCH)

    Portland, Oregon

    I'm interested

  • Medical University of South Carolina Children's Health (MUSC)

    Charleston, South Carolina

    I'm interested

  • Vanderbilt University & Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee

    I'm interested

  • University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)

    Memphis, Tennessee

    I'm interested

  • The University of Texas Health Science Center at Houston

    Houston, Texas

    I'm interested

  • University of Utah & Primary Children's Hospital (Utah-PCH)

    Salt Lake City, Utah

    I'm interested

  • University of Washington & Seattle Children's Hospital (UW-SCH)

    Seattle, Washington

    I'm interested
Who can participate

Inclusion criteria

  • ✓Postnatal, live born neonates with CDH
  • ✓a. Presence of associated or additional anomalies is acceptable for inclusion
  • ✓Bochdalek hernia location (right or left)
  • ✓Diagnosed prior to 1 month of life
  • ✓Born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial

Exclusion criteria

  • ✕CDH diagnosis after 1 month of age
  • ✕Morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location)
  • ✕Transferred to a CDH Study Group (CDHSG) member center after 1 week of life
  • ✕Patients without potential access to iNO

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.