Recruiting

iNO

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05213676

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Inhaled Nitric Oxide (iNO) use

De-implementation of Inhaled Nitric Oxide (iNO) use

Study Details

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

Study ID

NCT05213676

Start date

Nov 1, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2031

Anticipated

Primary completion date

Oct 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Matthew Harting, MD, MS, FACS

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

Ashley Ebanks

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

Locations

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

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Scott Anderson, MD

Scott.Anderson@childrensal.org

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

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Sid Dassinger, MD

dassingermelvins@uams.edu

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

Recruiting

Irvine, California, United States, 92868

Contacts

Yigit S Guner, MD, MS

YGuner@choc.org

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

Recruiting

Los Angeles, California, United States, 90027

Contacts

Rachel Chapman, MD

rachapman@chla.usc.edu

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

Recruiting

Palo Alto, California, United States, 94304

Contacts

Krisa Van Meurs, MD

vanmeurs@stanford.edu

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

Recruiting

San Diego, California, United States, 92123

Contacts

Denise Suttner, MD

dsuttner@rchsd.org

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

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jason Gien, MD

Jason.Gien@childrenscolorado.org

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

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sarah Keene, MD

skeene@emory.edu

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

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Brian W Gray, MD

graybw@iupui.edu

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

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Tiffany Wright, MD

tiffany.wright.1@louisville.edu

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

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jill Zalieckas, MD, MPH

Jill.Zalieckas@childrens.harvard.edu

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Erin Perrone, MD

eperrone@med.umich.edu

Randall Children's Hospital-Portland (RCH)

Recruiting

Portland, Oregon, United States, 97227

Contacts

Cynthia Gindalewski, MD

cgingale@lhs.org

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

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Laura E Hollinger, MD

hollingl@musc.edu

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

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Mark F Weems, MD

mweems@uthsc.edu

Vanderbilt University & Vanderbilt University Medical Center (VUMC)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Emily A Morris, MD

emily.a.morris@vumc.org

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Matthew Harting, MD, MS, FACS

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

Ashley Ebanks

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

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

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Katie W Russell, MD

Katie.Russell@hsc.utah.edu

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

Recruiting

Seattle, Washington, United States, 98105

Contacts

Rebecca Stark, MD

Rebecca.stark@seattlechildrens.org

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • CDH
  • Inhaled Nitric Oxide
  • Pulmonary Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-18.