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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
Who can join
0 Months – 1 Month · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the study
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.
What is being tested
- Inhaled Nitric Oxide (iNO) use (drug)
- De-implementation of Inhaled Nitric Oxide (iNO) use (other)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 600 · Started: Nov 1, 2025
Contact the study team
- Matthew Harting, MD, MS, FACS · Phone: (713) 500-7398
- Ashley Ebanks · Phone: (832) 325-7234
Official record on ClinicalTrials.gov — NCT05213676
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.