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

Phase 4

Not yet recruiting

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Other: De-implementation of Inhaled Nitric Oxide (iNO) use; Drug: Inhaled Nitric Oxide (iNO) use

• Registration Number: NCT05213676
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29
• Study Start: 2025-01-01
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
De-implementation of Inhaled Nitric Oxide (iNO) use	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).
Inhaled Nitric Oxide (iNO) use	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.

Primary Outcome Measures

Name	Time	Method
Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge	from birth through hospital discharge (upto 12 months from birth)	The primary outcome is the composite outcome of ECLS use and/or mortality.

Secondary Outcome Measures

Name	Time	Method
Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge	from birth through hospital discharge (upto 12 months from birth)
Number of participants that die prior to discharge	from birth through hospital discharge (upto 12 months from birth)
Change in oxygenation	6 hours after initiation of iNO use	For the iNO de-implementation arm, participants will be assessed 6 hours after the time when iNO would have been initiated, per the protocol of the center.
Total cost of initial inpatient care from birth through hospital discharge, per center	from birth through hospital discharge (upto 12 months from birth)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States