NCT05213676RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 27 Jan 2022
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- The University of Texas Health Science Center, Houston
- NCT number
- NCT05213676
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 900
- From 1 Nov 2025 to the primary completion date, 31 Oct 2030
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- CDH diagnosis after 1 month of age
Other
- 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
Who the study is looking for
- 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
Age in the registry: 0 months to 1 month · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan & CS Mott Children's Hospital (UM-CSMott) Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University & Children's Healthcare of Atlanta (CHOA) Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Colorado & Children's Hospital of Colorado (CU-CHC) Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Alabama & Children's Hospital of Alabama (UAB-CoA) Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Harvard University & Boston Children's Hospital (Harvard-BCH) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Medical University of South Carolina Children's Health (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University & Riley Children's Hospital (IU-RiCH) Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Arkansas & Arkansas Children's Hospital (UA-ACH) Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of Southern California & Children's Hospital Los Angeles (USC-CHLA) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Louisville & Norton Children's Hospital (UL-NCH) Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Vanderbilt University & Vanderbilt University Medical Center (VUMC) Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Randall Children's Hospital-Portland (RCH) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Utah & Primary Children's Hospital (Utah-PCH) Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| University of California, San Diego & Rady Children's Hospital (UCSD-Rady) Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of Washington & Seattle Children's Hospital (UW-SCH) Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.