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
Crossover
Inhaled Nitric Oxide (iNO) use
DrugThe 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
Other interventionThe center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge
The primary outcome is the composite outcome of ECLS use and/or mortality.
Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge
Number of participants who die prior to discharge
Change in oxygenation
For the iNO de-implementation arm, participants will be assessed 1 hour after the time when iNO would have been initiated, per the protocol of the center.
Change in oxygenation
For the iNO de-implementation arm, participants will be assessed 6 hours after the time when iNO would have been initiated, per the protocol of the center.
Click on the lead sponsor to view all of their trials.
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
