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De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

StatusRecruiting
PhasePhase 4
Started2025-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-14
Study Status v3
Re-verified, no change to tracked fields
2026-02-04
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-12-31→2030-10-31
Completion date2030-12-31→2031-04-30
Start dateestimated 2025-01-01→confirmed 2025-11-01
Study sites1→19
Secondary endpoints5 entries, revised
Number of participants thatwho require Extracorporeal Life Support (ECLS) prior to discharge Number of participants thatwho die prior to discharge
Primary endpoints1 entry, revised
Number of participants thatwho require Extracorporeal Life Support (ECLS) and/or thatwho die prior to discharge
Collaborators+908 characters
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) Children's Hospital of Orange County Medical University of South Carolina Children's Health (MUSC) University of Michigan & CS Mott Children's Hospital (UM-CSMott) Randall Children's Hospital-Portland (RCH) Stanford University & Lucil [...]
Study title-128 characters
De-implementing 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
2023-06-27
Study Status, Sponsor/Collaborators v1
Primary completion date2028-01-30→2029-12-31
Completion date2028-01-30→2030-12-31
Start date2023-01-01→2025-01-01
2022-01-27
Original filing
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.
Trial Details
NCT Number NCT05213676
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: University of Tennessee & LeBonheur Children's Hospital (UT-LBCH), Children's Hospital of Orange County, Medical University of South Carolina Children's Health (MUSC), University of Michigan & CS Mott Children's Hospital (UM-CSMott), Randall Children's Hospital-Portland (RCH), Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH), Rady Children's Hospital, San Diego, Boston Children's Hospital, Indiana University & Riley Children's Hospital (IU-RiCH), Norton Children's Hospital, University of Utah & Primary Children's Hospital (Utah-PCH), University of Washington & Seattle Children's Hospital (UW-SCH), University of Alabama & Children's Hospital of Alabama (UAB-CoA), University of Arkansas, Vanderbilt University Medical Center, University of Southern California & Children's Hospital Los Angeles (USC-CHLA), Emory University & Children's Healthcare of Atlanta (CHOA), Children's Hospital Colorado
Conditions Congenital Diaphragmatic Hernia
Enrollment 600 participants
Start Date 2025-11-01
Primary Completion 2030-10-31 (estimated)
Study Completion 2031-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-18