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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…

ClinicalTrials.gov IDNCT05213676

PhasePHASE4

Enrollment600

SponsorThe University of Texas Health Science Center, Houston

Age0 Months

SexALL

I'm interested View official listing

Conditions studied

Congenital Diaphragmatic Hernia

About this study

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 outcomes

Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge (from birth through hospital discharge (up to 12 months from birth))

Eligibility information

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 locations

University of Alabama & Children's Hospital of Alabama (UAB-CoA), Birmingham, Alabama 35233 United States
University of Arkansas & Arkansas Children's Hospital (UA-ACH), Little Rock, Arkansas 72202 United States
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC), Irvine, California 92868 United States
University of Southern California & Children's Hospital Los Angeles (USC-CHLA), Los Angeles, California 90027 United States
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH), Palo Alto, California 94304 United States
University of California, San Diego & Rady Children's Hospital (UCSD-Rady), San Diego, California 92123 United States
University of Colorado & Children's Hospital of Colorado (CU-CHC), Aurora, Colorado 80045 United States
Emory University & Children's Healthcare of Atlanta (CHOA), Atlanta, Georgia 30322 United States
Indiana University & Riley Children's Hospital (IU-RiCH), Indianapolis, Indiana 46202 United States
University of Louisville & Norton Children's Hospital (UL-NCH), Louisville, Kentucky 40202 United States

Showing 10 of 19 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.