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

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05213676
• Other study ID #: HSC-MS-21-0603
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2025
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Matthew Harting, MD, MS, FACS
• Phone: (713) 500-7398
• Email: Matthew.T.Harting[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge	The primary outcome is the composite outcome of ECLS use and/or mortality.	from birth through hospital discharge (upto 12 months from birth)
Secondary	Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge		from birth through hospital discharge (upto 12 months from birth)
Secondary	Number of participants that die prior to discharge		from birth through hospital discharge (upto 12 months from birth)
Secondary	Change in oxygenation	For the iNO de-implementation arm, participants will be assessed 1 hour after the time when iNO would have been initiated, per the protocol of the center.	1 hour after initiation of iNO use
Secondary	Change in oxygenation	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.	6 hours after initiation of iNO use
Secondary	Total cost of initial inpatient care from birth through hospital discharge, per center		from birth through hospital discharge (upto 12 months from birth)