De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Purpose

The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing 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.

Condition

  • Congenital Diaphragmatic Hernia

Eligibility

Eligible Ages
Between 0 Months and 1 Month
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • 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).
Active Comparator
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).
  • 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).

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Matthew Harting, MD, MS, FACS
(713) 500-7398
Matthew.T.Harting@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew Harting, MD, MS, FACS
(713) 500-7398
Matthew.T.Harting@uth.tmc.edu

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.