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De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Sponsor: The University of Texas Health Science Center, Houston
Summary
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.
Official title: Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative
Key Details
Gender
All
Age Range
0 Months - 1 Month
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-11-01
Completion Date
2031-04-30
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Inhaled Nitric Oxide (iNO) use
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.
De-implementation of Inhaled Nitric Oxide (iNO) use
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Locations (19)
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