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.
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
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
The University of Texas Health Science Center, Houston
Lead sponsor
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Collaborator
Children's Hospital of Orange County
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
Rady Children's Hospital, San Diego
Collaborator
Boston Children's Hospital
Collaborator
Indiana University & Riley Children's Hospital (IU-RiCH)
Collaborator
Norton 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 Arkansas
Collaborator
Vanderbilt University Medical Center
Collaborator
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Collaborator
Emory University & Children's Healthcare of Atlanta (CHOA)
Collaborator
Children's Hospital Colorado
Collaborator