De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Recruiting now · Phase 4
Conditions studied: Congenital Diaphragmatic Hernia
In brief
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.
Key facts
- Study ID
- NCT05213676
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 600
- Starts
- 2025-11-01
- Expected to finish
- 2031-04-30
- Last updated by the study team
- 2026-02-09
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama & Children's Hospital of Alabama (UAB-CoA) — Birmingham, Alabama, United States (enrolling)
- University of Arkansas & Arkansas Children's Hospital (UA-ACH) — Little Rock, Arkansas, United States (enrolling)
- University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) — Irvine, California, United States (enrolling)
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA) — Los Angeles, California, United States (enrolling)
- Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) — Palo Alto, California, United States (enrolling)
- University of California, San Diego & Rady Children's Hospital (UCSD-Rady) — San Diego, California, United States (enrolling)
- University of Colorado & Children's Hospital of Colorado (CU-CHC) — Aurora, Colorado, United States (enrolling)
- Emory University & Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States (enrolling)
- Indiana University & Riley Children's Hospital (IU-RiCH) — Indianapolis, Indiana, United States (enrolling)
- University of Louisville & Norton Children's Hospital (UL-NCH) — Louisville, Kentucky, United States (enrolling)
- Harvard University & Boston Children's Hospital (Harvard-BCH) — Boston, Massachusetts, United States (enrolling)
- University of Michigan & CS Mott Children's Hospital (UM-CSMott) — Ann Arbor, Michigan, United States (enrolling)
- Randall Children's Hospital-Portland (RCH) — Portland, Oregon, United States (enrolling)
- Medical University of South Carolina Children's Health (MUSC) — Charleston, South Carolina, United States (enrolling)
- University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) — Memphis, Tennessee, United States (enrolling)
- Vanderbilt University & Vanderbilt University Medical Center (VUMC) — Nashville, Tennessee, United States (enrolling)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
- University of Utah & Primary Children's Hospital (Utah-PCH) — Salt Lake City, Utah, United States (enrolling)
- University of Washington & Seattle Children's Hospital (UW-SCH) — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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