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RECRUITING Phase 4 ClinicalTrials.gov

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Sponsor: The University of Texas Health Science Center, Houston • ClinicalTrials.gov ID: NCT05213676

Registry updated: 2026-08-18
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Description

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.

Interventions

  • Inhaled Nitric Oxide (iNO) use (Drug)
    The center will use iNO per their usual protocol in the initial resuscitation period (defined as birth through stabilization and CDH repair). No center will alter any component of their standard clinical practice guideline or protocol governing CDH care.
  • De-implementation of Inhaled Nitric Oxide (iNO) use (Other)
    The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).

Eligibility criteria

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

Conditions

Congenital Diaphragmatic Hernia

Locations

  • University of Alabama & Children's Hospital of Alabama (UAB-CoA) — Birmingham, Alabama, United States
  • University of Arkansas & Arkansas Children's Hospital (UA-ACH) — Little Rock, Arkansas, United States
  • University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) — Irvine, California, United States
  • University of Southern California & Children's Hospital Los Angeles (USC-CHLA) — Los Angeles, California, United States
  • Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) — Palo Alto, California, United States
  • University of California, San Diego & Rady Children's Hospital (UCSD-Rady) — San Diego, California, United States
  • University of Colorado & Children's Hospital of Colorado (CU-CHC) — Aurora, Colorado, United States
  • Emory University & Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States
  • Indiana University & Riley Children's Hospital (IU-RiCH) — Indianapolis, Indiana, United States
  • University of Louisville & Norton Children's Hospital (UL-NCH) — Louisville, Kentucky, United States
  • Harvard University & Boston Children's Hospital (Harvard-BCH) — Boston, Massachusetts, United States
  • University of Michigan & CS Mott Children's Hospital (UM-CSMott) — Ann Arbor, Michigan, United States
  • Randall Children's Hospital-Portland (RCH) — Portland, Oregon, United States
  • Medical University of South Carolina Children's Health (MUSC) — Charleston, South Carolina, United States
  • University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) — Memphis, Tennessee, United States
  • Vanderbilt University & Vanderbilt University Medical Center (VUMC) — Nashville, Tennessee, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • University of Utah & Primary Children's Hospital (Utah-PCH) — Salt Lake City, Utah, United States
  • University of Washington & Seattle Children's Hospital (UW-SCH) — Seattle, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record