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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

NCT07247240

Congenital Diaphragmatic Hernia Pulmonary Hypertension

NOT_YET_RECRUITING PHASE4

Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

NCT00005773

Infant, Newborn Hypertension, Pulmonary Persistent Fetal Circulation Syndrome +3 more

TERMINATED PHASE3

Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

NCT00955487

Bronchopulmonary Dysplasia

COMPLETED PHASE2

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

NCT03314233

Congenital Diaphragmatic Hernia

COMPLETED NA

Extubation Readiness Study in Very Low Birthweight Infants

NCT01471431

Respiratory Distress Syndrome

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Diaphragmatic Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Inhaled Nitric Oxide (iNO) use

Intervention Type DRUG

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.

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).

Group Type ACTIVE_COMPARATOR

De-implementation of Inhaled Nitric Oxide (iNO) use

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

0 Months

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No