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

The University of Texas System (UT)

Status and phase

Not yet enrolling

Phase 4

Conditions

Congenital Diaphragmatic Hernia

Treatments

Drug: Inhaled Nitric Oxide (iNO) use

Other: De-implementation of Inhaled Nitric Oxide (iNO) use

Study type

Interventional

Funder types

Other

Identifiers

NCT05213676

HSC-MS-21-0603

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

600 participants in 2 patient groups

Inhaled Nitric Oxide (iNO) use

Active Comparator group

Description:

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.

Treatment:

Drug: Inhaled Nitric Oxide (iNO) use

De-implementation of Inhaled Nitric Oxide (iNO) use

Active Comparator group

Description:

The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).

Treatment:

Other: De-implementation of Inhaled Nitric Oxide (iNO) use