De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Recruiting · NCT05213676 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center, Houston
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
19 locations listed across 15 US states.
- University of Alabama & Children's Hospital of Alabama (UAB-CoA) - Birmingham, Alabama, United States
- University of Arkansas & Arkansas Children's Hospital (UA-ACH) - Little Rock, Arkansas, United States
- University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) - Irvine, California, United States
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA) - Los Angeles, California, United States
- Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) - Palo Alto, California, United States
- University of California, San Diego & Rady Children's Hospital (UCSD-Rady) - San Diego, California, United States
- University of Colorado & Children's Hospital of Colorado (CU-CHC) - Aurora, Colorado, United States
- Emory University & Children's Healthcare of Atlanta (CHOA) - Atlanta, Georgia, United States
- Indiana University & Riley Children's Hospital (IU-RiCH) - Indianapolis, Indiana, United States
- University of Louisville & Norton Children's Hospital (UL-NCH) - Louisville, Kentucky, United States
- Harvard University & Boston Children's Hospital (Harvard-BCH) - Boston, Massachusetts, United States
- University of Michigan & CS Mott Children's Hospital (UM-CSMott) - Ann Arbor, Michigan, United States
- Randall Children's Hospital-Portland (RCH) - Portland, Oregon, United States
- Medical University of South Carolina Children's Health (MUSC) - Charleston, South Carolina, United States
- University of Tennessee & LeBonheur Children's Hospital (UT-LBCH) - Memphis, Tennessee, United States
- Vanderbilt University & Vanderbilt University Medical Center (VUMC) - Nashville, Tennessee, United States
- The University of Texas Health Science Center at Houston - Houston, Texas, United States
- University of Utah & Primary Children's Hospital (Utah-PCH) - Salt Lake City, Utah, United States
- University of Washington & Seattle Children's Hospital (UW-SCH) - Seattle, Washington, United States