Clinical trial

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

Name

HSC-MS-21-0603

Description

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.

Trial arms

Trial start

2025-01-01

Estimated PCD

2029-12-31

Trial end

2030-12-31

Status

Not yet recruiting

Phase

Early phase I

Treatment

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.

Arms:

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).

Arms:

De-implementation of Inhaled Nitric Oxide (iNO) use

Size

600

Primary endpoint

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)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO deimplementation (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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

Updated at

2023-06-29

1 organization

1 product

1 indication

Organization

The University of Texas Health Science Center at Houston

Product

Inhaled Nitric Oxide

Indication

Congenital Diaphragmatic Hernia