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De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
NCT05213676 · The University of Texas Health Science Center, Houston
In plain English
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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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2025-11-01
Estimated completion: 2031-04-30
Last updated: 2026-02-09
Interventions
Drug: Inhaled Nitric Oxide (iNO) useOther: De-implementation of Inhaled Nitric Oxide (iNO) use
Primary outcomes
- • Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge (from birth through hospital discharge (up to 12 months from birth))
Sponsor
The University of Texas Health Science Center, Houston · other
With: University of Tennessee & LeBonheur Children's Hospital (UT-LBCH), University of California-Irvine & Children's Hospital of Orange County (UC-CHOC), Medical University of South Carolina Children's Health (MUSC), University of Michigan & CS Mott Children's Hospital (UM-CSMott), Randall Children's Hospital-Portland (RCH), Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH), University of California, San Diego & Rady Children's Hospital (UCSD-Rady), Boston Children's Hospital, Indiana University & Riley Children's Hospital (IU-RiCH), Norton Children's Hospital, University of Utah & Primary Children's Hospital (Utah-PCH), University of Washington & Seattle Children's Hospital (UW-SCH), University of Alabama & Children's Hospital of Alabama (UAB-CoA), University of Arkansas & Arkansas Children's Hospital (UA-ACH), Vanderbilt University & Vanderbilt University Medical Center (VUMC), University of Southern California & Children's Hospital Los Angeles (USC-CHLA), Emory University & Children's Healthcare of Atlanta (CHOA), University of Colorado & Children's Hospital of Colorado (CU-CHC)
Contacts & investigators
ContactMatthew Harting, MD, MS, FACS · contact · Matthew.T.Harting@uth.tmc.edu · (713) 500-7398
ContactAshley Ebanks · contact · Ashley.Harmon@uth.tmc.edu · (832) 325-7234
InvestigatorMatthew Harting, MD, MS, FACS · principal_investigator, The University of Texas Health Science Center, Houston
All locations (19)
University of Alabama & Children's Hospital of Alabama (UAB-CoA)Recruiting
Birmingham, Alabama, United States
University of Arkansas & Arkansas Children's Hospital (UA-ACH)Recruiting
Little Rock, Arkansas, United States
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)Recruiting
Irvine, California, United States
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)Recruiting
Los Angeles, California, United States
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)Recruiting
Palo Alto, California, United States
University of California, San Diego & Rady Children's Hospital (UCSD-Rady)Recruiting
San Diego, California, United States
University of Colorado & Children's Hospital of Colorado (CU-CHC)Recruiting
Aurora, Colorado, United States
Emory University & Children's Healthcare of Atlanta (CHOA)Recruiting
Atlanta, Georgia, United States
Indiana University & Riley Children's Hospital (IU-RiCH)Recruiting
Indianapolis, Indiana, United States
University of Louisville & Norton Children's Hospital (UL-NCH)Recruiting
Louisville, Kentucky, United States
Harvard University & Boston Children's Hospital (Harvard-BCH)Recruiting
Boston, Massachusetts, United States
University of Michigan & CS Mott Children's Hospital (UM-CSMott)Recruiting
Ann Arbor, Michigan, United States
Randall Children's Hospital-Portland (RCH)Recruiting
Portland, Oregon, United States
Medical University of South Carolina Children's Health (MUSC)Recruiting
Charleston, South Carolina, United States
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)Recruiting
Memphis, Tennessee, United States
Vanderbilt University & Vanderbilt University Medical Center (VUMC)Recruiting
Nashville, Tennessee, United States
The University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States
University of Utah & Primary Children's Hospital (Utah-PCH)Recruiting
Salt Lake City, Utah, United States
University of Washington & Seattle Children's Hospital (UW-SCH)Recruiting
Seattle, Washington, United States