Clinical trial NCT05213676: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Congenital Diaphragmatic Hernia
Keywords: CDH
Inhaled Nitric Oxide
Pulmonary hypertension
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge
timeFrame: from birth through hospital discharge (upto 12 months from birth)
Secondary outcomes:
measure: Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
timeFrame: from birth through hospital discharge (upto 12 months from birth)
measure: Number of participants that die prior to discharge
timeFrame: from birth through hospital discharge (upto 12 months from birth)
measure: Change in oxygenation
timeFrame: 1 hour after initiation of iNO use
measure: Change in oxygenation
timeFrame: 6 hours after initiation of iNO use
measure: Total cost of initial inpatient care from birth through hospital discharge, per center
timeFrame: from birth through hospital discharge (upto 12 months from birth)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew Harting, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: