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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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan & CS Mott Children's Hospital (UM-CSMott)
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Emory University & Children's Healthcare of Atlanta (CHOA)
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
University of Colorado & Children's Hospital of Colorado (CU-CHC)
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Harvard University & Boston Children's Hospital (Harvard-BCH)
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Medical University of South Carolina Children's Health (MUSC)
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
The University of Texas Health Science Center at Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Indiana University & Riley Children's Hospital (IU-RiCH)
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
University of Arkansas & Arkansas Children's Hospital (UA-ACH)
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
University of Louisville & Norton Children's Hospital (UL-NCH)
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Vanderbilt University & Vanderbilt University Medical Center (VUMC)
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting
Randall Children's Hospital-Portland (RCH)
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
University of Utah & Primary Children's Hospital (Utah-PCH)
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
University of Washington & Seattle Children's Hospital (UW-SCH)
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.