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Recruiting NCT05213676

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Phase IV Interventional Congenital Diaphragmatic Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhaled Nitric Oxide (iNO) use, De-implementation of Inhaled Nitric Oxide (iNO) use.
Who it may be relevant to
Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: 0 months — 1 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • 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).

Primary outcome measures

  • Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge [Time frame: from birth through hospital discharge (up to 12 months from birth)]
Secondary outcome measures (5)
  • Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge [Time frame: from birth through hospital discharge (up to 12 months from birth)]
  • Number of participants who die prior to discharge [Time frame: from birth through hospital discharge (up to 12 months from birth)]
  • Change in oxygenation [Time frame: 1 hour after initiation of iNO use]
  • Change in oxygenation [Time frame: 6 hours after initiation of iNO use]
  • Total cost of initial inpatient care from birth through hospital discharge, per center [Time frame: from birth through hospital discharge (up to 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 19 centers
  • University of Alabama & Children's Hospital of Alabama (UAB-CoA) — Birmingham
  • University of Arkansas & Arkansas Children's Hospital (UA-ACH) — Little Rock
  • University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) — Irvine
  • University of Southern California & Children's Hospital Los Angeles (USC-CHLA) — Los Angeles
  • Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) — Palo Alto
  • University of California, San Diego & Rady Children's Hospital (UCSD-Rady) — San Diego
  • University of Colorado & Children's Hospital of Colorado (CU-CHC) — Aurora
  • Emory University & Children's Healthcare of Atlanta (CHOA) — Atlanta
  • … and 11 more centers

Identifiers

NCT: NCT05213676 · HSC-MS-21-0603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗