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.
In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
Birmingham, Alabama, United States
RECRUITINGUniversity of Arkansas & Arkansas Children's Hospital (UA-ACH)
Little Rock, Arkansas, United States
RECRUITINGUniversity of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
Irvine, California, United States
RECRUITINGUniversity of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Los Angeles, California, United States
RECRUITINGStanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Palo Alto, California, United States
RECRUITINGUniversity of California, San Diego & Rady Children's Hospital (UCSD-Rady)
San Diego, California, United States
RECRUITINGUniversity of Colorado & Children's Hospital of Colorado (CU-CHC)
Aurora, Colorado, United States
RECRUITINGEmory University & Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States
RECRUITINGIndiana University & Riley Children's Hospital (IU-RiCH)
Indianapolis, Indiana, United States
RECRUITINGUniversity of Louisville & Norton Children's Hospital (UL-NCH)
Louisville, Kentucky, United States
RECRUITING...and 9 more locations
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.
Time frame: from birth through hospital discharge (up to 12 months from birth)
Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge
Time frame: from birth through hospital discharge (up to 12 months from birth)
Number of participants who die prior to discharge
Time frame: from birth through hospital discharge (up to 12 months from birth)
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.
Time frame: 1 hour after initiation of iNO use
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.
Time frame: 6 hours after initiation of iNO use
Total cost of initial inpatient care from birth through hospital discharge, per center
Time frame: from birth through hospital discharge (up to 12 months from birth)
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