NCT05213676

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 0 Months – 1 Month
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide (iNO) use	The center will use iNO per their usual protocol in the initial resuscitation period (defined as birth through stabilization and CDH repair). No center will alter any component of their standard clinical practice guideline or protocol governing CDH care.
OTHER	De-implementation of Inhaled Nitric Oxide (iNO) use	The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).

Timeline

• Start date: 2025-11-01
• Primary completion: 2030-10-31
• Completion: 2031-04-30
• First posted: 2022-01-28
• Last updated: 2026-02-09

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study