De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

NCT05213676 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HSC-MS-21-0603
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

CDH; Inhaled Nitric Oxide; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge

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

  from birth through hospital discharge (up to 12 months from birth)

Secondary Outcomes (5)

• Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge

  from birth through hospital discharge (up to 12 months from birth)

• Number of participants who die prior to discharge

  from birth through hospital discharge (up to 12 months from birth)

• Change in oxygenation

  1 hour after initiation of iNO use

• Change in oxygenation

  6 hours after initiation of iNO use

• Total cost of initial inpatient care from birth through hospital discharge, per center

  from birth through hospital discharge (up to 12 months from birth)

Study Arms (2)

Inhaled Nitric Oxide (iNO) use

ACTIVE COMPARATOR

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

De-implementation of Inhaled Nitric Oxide (iNO) use

ACTIVE COMPARATOR

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

Interventions

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).

De-implementation of Inhaled Nitric Oxide (iNO) use

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.

Inhaled Nitric Oxide (iNO) use

Eligibility Criteria

• Age: 0 Months - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postnatal, live born neonates with CDH
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (19)

University of Alabama & Children's Hospital of Alabama (UAB-CoA)

Birmingham, Alabama, 35233, United States

RECRUITING

University of Arkansas & Arkansas Children's Hospital (UA-ACH)

Little Rock, Arkansas, 72202, United States

RECRUITING

University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)

Irvine, California, 92868, United States

RECRUITING

University of Southern California & Children's Hospital Los Angeles (USC-CHLA)

Los Angeles, California, 90027, United States

RECRUITING

Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)

Palo Alto, California, 94304, United States

RECRUITING

University of California, San Diego & Rady Children's Hospital (UCSD-Rady)

San Diego, California, 92123, United States

RECRUITING

University of Colorado & Children's Hospital of Colorado (CU-CHC)

Aurora, Colorado, 80045, United States

RECRUITING

Emory University & Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States

RECRUITING

Indiana University & Riley Children's Hospital (IU-RiCH)

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Louisville & Norton Children's Hospital (UL-NCH)

Louisville, Kentucky, 40202, United States

RECRUITING

Harvard University & Boston Children's Hospital (Harvard-BCH)

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan & CS Mott Children's Hospital (UM-CSMott)

Ann Arbor, Michigan, 48109, United States

RECRUITING

Randall Children's Hospital-Portland (RCH)

Portland, Oregon, 97227, United States

RECRUITING

Medical University of South Carolina Children's Health (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)

Memphis, Tennessee, 38105, United States

RECRUITING

Vanderbilt University & Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, 37232, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

University of Utah & Primary Children's Hospital (Utah-PCH)

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Washington & Seattle Children's Hospital (UW-SCH)

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hypertension, Pulmonary

Interventions

Inosine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Matthew Harting, MD, MS, FACS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Harting, MD, MS, FACS

CONTACT

(713) 500-7398; Matthew.T.Harting@uth.tmc.edu

Ashley Ebanks

CONTACT

(832) 325-7234; Ashley.Harmon@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: January 28, 2022
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): April 30, 2031
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)