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NCT Number: NCT05213676

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

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.

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Key information

Conditions

Congenital Diaphragmatic Hernia Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Hypertension Hypertension, Pulmonary Internal Hernia Lung Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Vascular Diseases

Age range

0 month–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama & Children's Hospital of Alabama (UAB-CoA), Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Nitric Oxide (iNO) use

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

Other

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

Primary outcomes

  1. 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)

    The primary outcome is the composite outcome of ECLS use and/or mortality.

Secondary outcomes

  1. 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)

  2. Number of participants who die prior to discharge

    Time frame: from birth through hospital discharge (up to 12 months from birth)

  3. Change in oxygenation

    Time frame: 1 hour after initiation of iNO use

    For the iNO de-implementation arm, participants will be assessed 1 hour after the time when iNO would have been initiated, per the protocol of the center.

  4. Change in oxygenation

    Time frame: 6 hours after initiation of iNO use

    For the iNO de-implementation arm, participants will be assessed 6 hours after the time when iNO would have been initiated, per the protocol of the center.

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Ebanks

CONTACT

[email protected]

(832) 325-7234

Matthew Harting, MD, MS, FACS

CONTACT

[email protected]

(713) 500-7398

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Boston Children's Hospital
  • Children's Hospital Colorado
  • Children's Hospital of Orange County
  • Emory University & Children's Healthcare of Atlanta (CHOA)
  • Indiana University & Riley Children's Hospital (IU-RiCH)
  • Medical University of South Carolina Children's Health (MUSC)
  • Norton Children's Hospital
  • Rady Children's Hospital, San Diego
  • Randall Children's Hospital-Portland (RCH)
  • Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
  • University of Alabama & Children's Hospital of Alabama (UAB-CoA)
  • University of Arkansas
  • University of Michigan & CS Mott Children's Hospital (UM-CSMott)
  • University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
  • University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
  • University of Utah & Primary Children's Hospital (Utah-PCH)
  • University of Washington & Seattle Children's Hospital (UW-SCH)
  • Vanderbilt University Medical Center

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jan 28, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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