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

• Status: Not yet recruiting
• Trial end date: 2028-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to Determine if deimplementation of iNO in the post-natal resuscitation/stabilization phase affects the composite outcome of ECLS use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in CDH newborns and to establish the cost-effectiveness of deimplementing 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Nitric Oxide

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