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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 0 Months and 1 Month
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: 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.
  • Other: 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).
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).
  • Other: 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).

Recruiting Locations

University of Alabama & Children's Hospital of Alabama (UAB-CoA)
Birmingham, Alabama 35233
Contact:
Scott Anderson, MD
Scott.Anderson@childrensal.org

University of Arkansas & Arkansas Children's Hospital (UA-ACH)
Little Rock, Arkansas 72202
Contact:
Sid Dassinger, MD
dassingermelvins@uams.edu

University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
Irvine, California 92868
Contact:
Yigit S Guner, MD, MS
YGuner@choc.org

University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Los Angeles, California 90027
Contact:
Rachel Chapman, MD
rachapman@chla.usc.edu

Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Palo Alto, California 94304
Contact:
Krisa Van Meurs, MD
vanmeurs@stanford.edu

University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
San Diego, California 92123
Contact:
Denise Suttner, MD
dsuttner@rchsd.org

University of Colorado & Children's Hospital of Colorado (CU-CHC)
Aurora, Colorado 80045
Contact:
Jason Gien, MD
Jason.Gien@childrenscolorado.org

Emory University & Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia 30322
Contact:
Sarah Keene, MD
skeene@emory.edu

Indiana University & Riley Children's Hospital (IU-RiCH)
Indianapolis, Indiana 46202
Contact:
Brian W Gray, MD
graybw@iupui.edu

University of Louisville & Norton Children's Hospital (UL-NCH)
Louisville, Kentucky 40202
Contact:
Tiffany Wright, MD
tiffany.wright.1@louisville.edu

Harvard University & Boston Children's Hospital (Harvard-BCH)
Boston, Massachusetts 02115
Contact:
Jill Zalieckas, MD, MPH
Jill.Zalieckas@childrens.harvard.edu

University of Michigan & CS Mott Children's Hospital (UM-CSMott)
Ann Arbor, Michigan 48109
Contact:
Erin Perrone, MD
eperrone@med.umich.edu

Randall Children's Hospital-Portland (RCH)
Portland, Oregon 97227
Contact:
Cynthia Gindalewski, MD
cgingale@lhs.org

Medical University of South Carolina Children's Health (MUSC)
Charleston, South Carolina 29425
Contact:
Laura E Hollinger, MD
hollingl@musc.edu

University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Memphis, Tennessee 38105
Contact:
Mark F Weems, MD
mweems@uthsc.edu

Vanderbilt University & Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee 37232
Contact:
Emily A Morris, MD
emily.a.morris@vumc.org

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew Harting, MD, MS, FACS
(713) 500-7398
Matthew.T.Harting@uth.tmc.edu

University of Utah & Primary Children's Hospital (Utah-PCH)
Salt Lake City, Utah 84108
Contact:
Katie W Russell, MD
Katie.Russell@hsc.utah.edu

University of Washington & Seattle Children's Hospital (UW-SCH)
Seattle, Washington 98105
Contact:
Rebecca Stark, MD
Rebecca.stark@seattlechildrens.org

More Details

NCT ID
NCT05213676
Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew Harting, MD, MS, FACS
(713) 500-7398
Matthew.T.Harting@uth.tmc.edu

Detailed Description

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.

Notice

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