Testing whether stopping inhaled nitric oxide use helps newborns with congenital diaphragmatic hernia
Tests stopping inhaled nitric oxide use in newborns with congenital diaphragmatic hernia.
Plain-language title generated from the registry record
Registry title: De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Key facts
- Where
- Ann Arbor, Atlanta, Aurora, Birmingham, Boston, Charleston, Houston, Indianapolis, Irvine, Little Rock, Los Angeles, Louisville, Memphis, Nashville, Palo Alto, Portland, Salt Lake City, San Diego, and Seattle, United StatesSee the 19 sites
- Phase
- Phase 4
Where in United States
- University of Michigan & CS Mott Children's Hospital (UM-CSMott)Ann Arbor, United StatesTaking people
- Emory University & Children's Healthcare of Atlanta (CHOA)Atlanta, United StatesTaking people
- University of Colorado & Children's Hospital of Colorado (CU-CHC)Aurora, United StatesTaking people
- University of Alabama & Children's Hospital of Alabama (UAB-CoA)Birmingham, United StatesTaking people
- Harvard University & Boston Children's Hospital (Harvard-BCH)Boston, United StatesTaking people
- Medical University of South Carolina Children's Health (MUSC)Charleston, United StatesTaking people
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- Indiana University & Riley Children's Hospital (IU-RiCH)Indianapolis, United StatesTaking people
- University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)Irvine, United StatesTaking people
- University of Arkansas & Arkansas Children's Hospital (UA-ACH)Little Rock, United StatesTaking people
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA)Los Angeles, United StatesTaking people
- University of Louisville & Norton Children's Hospital (UL-NCH)Louisville, United StatesTaking people
- University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)Memphis, United StatesTaking people
- Vanderbilt University & Vanderbilt University Medical Center (VUMC)Nashville, United StatesTaking people
- Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)Palo Alto, United StatesTaking people
- Randall Children's Hospital-Portland (RCH)Portland, United StatesTaking people
- University of Utah & Primary Children's Hospital (Utah-PCH)Salt Lake City, United StatesTaking people
- University of California, San Diego & Rady Children's Hospital (UCSD-Rady)San Diego, United StatesTaking people
- University of Washington & Seattle Children's Hospital (UW-SCH)Seattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center, Houston
- Trial code
- NCT05213676
- Record updated
- 29 October 2026
- Original 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.Read full original descriptionShow less
Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative
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.
Inclusion: Postnatal, live born neonates with CDH; 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: 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.