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.

NCT Number	NCT05213676
Lead Sponsor	The University of Texas Health Science Center, Houston Collaborators: University of Tennessee & LeBonheur Children's Hospital (UT-LBCH), Children's Hospital of Orange County, Medical University of South Carolina Children's Health (MUSC), University of Michigan & CS Mott Children's Hospital (UM-CSMott), Randall Children's Hospital-Portland (RCH), Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH), Rady Children's Hospital, San Diego, Boston Children's Hospital, Indiana University & Riley Children's Hospital (IU-RiCH), Norton Children's Hospital, University of Utah & Primary Children's Hospital (Utah-PCH), University of Washington & Seattle Children's Hospital (UW-SCH), University of Alabama & Children's Hospital of Alabama (UAB-CoA), University of Arkansas, Vanderbilt University Medical Center, University of Southern California & Children's Hospital Los Angeles (USC-CHLA), Emory University & Children's Healthcare of Atlanta (CHOA), Children's Hospital Colorado
Conditions	Congenital Diaphragmatic Hernia
Enrollment	600 participants
Start Date	2025-11-01
Primary Completion	2030-10-31 (estimated)
Study Completion	2031-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-09