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
Who is this study for? Patients with Congenital Diaphragmatic Hernia
What treatments are being studied? Inhaled Nitric Oxide (iNO)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
RECRUITING
Birmingham
Arkansas
University of Arkansas & Arkansas Children's Hospital (UA-ACH)
RECRUITING
Little Rock
California
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
RECRUITING
Irvine
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
RECRUITING
Los Angeles
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
RECRUITING
Palo Alto
University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
RECRUITING
San Diego
Colorado
University of Colorado & Children's Hospital of Colorado (CU-CHC)
RECRUITING
Aurora
Georgia
Emory University & Children's Healthcare of Atlanta (CHOA)
RECRUITING
Atlanta
Indiana
Indiana University & Riley Children's Hospital (IU-RiCH)
RECRUITING
Indianapolis
Kentucky
University of Louisville & Norton Children's Hospital (UL-NCH)
RECRUITING
Louisville
Massachusetts
Harvard University & Boston Children's Hospital (Harvard-BCH)
RECRUITING
Boston
Michigan
University of Michigan & CS Mott Children's Hospital (UM-CSMott)
RECRUITING
Ann Arbor
Oregon
Randall Children's Hospital-Portland (RCH)
RECRUITING
Portland
South Carolina
Medical University of South Carolina Children's Health (MUSC)
RECRUITING
Charleston
Tennessee
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
RECRUITING
Memphis
Vanderbilt University & Vanderbilt University Medical Center (VUMC)
RECRUITING
Nashville
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
University of Utah & Primary Children's Hospital (Utah-PCH)
RECRUITING
Salt Lake City
Washington
University of Washington & Seattle Children's Hospital (UW-SCH)
RECRUITING
Seattle
Contact Information
Primary
Matthew Harting, MD, MS, FACS
Matthew.T.Harting@uth.tmc.edu
(713) 500-7398
Backup
Ashley Ebanks
Ashley.Harmon@uth.tmc.edu
(832) 325-7234
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2031-04-30
Participants
Target number of participants: 600
Treatments
Active_comparator: 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.
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Collaborators: University of Colorado & Children's Hospital of Colorado (CU-CHC), University of California, San Diego & Rady Children's Hospital (UCSD-Rady), Emory University & Children's Healthcare of Atlanta (CHOA), University of Alabama & Children's Hospital of Alabama (UAB-CoA), Norton Children's Hospital, Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH), University of California-Irvine & Children's Hospital of Orange County (UC-CHOC), University of Michigan & CS Mott Children's Hospital (UM-CSMott), Vanderbilt University & Vanderbilt University Medical Center (VUMC), Medical University of South Carolina Children's Health (MUSC), Randall Children's Hospital-Portland (RCH), University of Utah & Primary Children's Hospital (Utah-PCH), University of Southern California & Children's Hospital Los Angeles (USC-CHLA), Boston Children's Hospital, University of Arkansas & Arkansas Children's Hospital (UA-ACH), University of Tennessee & LeBonheur Children's Hospital (UT-LBCH), University of Washington & Seattle Children's Hospital (UW-SCH), Indiana University & Riley Children's Hospital (IU-RiCH)
Leads: The University of Texas Health Science Center, Houston