Actively Recruiting
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-09
600
Participants Needed
19
Research Sites
286 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
U
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postnatal, live born neonates with congenital diaphragmatic hernia
- Presence of associated or additional anomalies is acceptable
- Bochdalek hernia location (right or left side)
- Diagnosed prior to 1 month of age
- Born within or transferred to a participating CDH Study Group (CDHSG) center within 1 week of life
You will not qualify if you...
- Diagnosis of congenital diaphragmatic hernia after 1 month of age
- Morgagni diaphragmatic hernia (central or anterior-medial defect location)
- Transferred to a CDH Study Group center after 1 week of life
- Patients without potential access to inhaled nitric oxide (iNO)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Arkansas & Arkansas Children's Hospital (UA-ACH)
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
Irvine, California, United States, 92868
Actively Recruiting
4
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Los Angeles, California, United States, 90027
Actively Recruiting
5
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Palo Alto, California, United States, 94304
Actively Recruiting
6
University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
San Diego, California, United States, 92123
Actively Recruiting
7
University of Colorado & Children's Hospital of Colorado (CU-CHC)
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Emory University & Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Indiana University & Riley Children's Hospital (IU-RiCH)
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Louisville & Norton Children's Hospital (UL-NCH)
Louisville, Kentucky, United States, 40202
Actively Recruiting
11
Harvard University & Boston Children's Hospital (Harvard-BCH)
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
University of Michigan & CS Mott Children's Hospital (UM-CSMott)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Randall Children's Hospital-Portland (RCH)
Portland, Oregon, United States, 97227
Actively Recruiting
14
Medical University of South Carolina Children's Health (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
15
University of Tennessee & LeBonheur Children's Hospital (UT-LBCH)
Memphis, Tennessee, United States, 38105
Actively Recruiting
16
Vanderbilt University & Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States, 37232
Actively Recruiting
17
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
18
University of Utah & Primary Children's Hospital (Utah-PCH)
Salt Lake City, Utah, United States, 84108
Actively Recruiting
19
University of Washington & Seattle Children's Hospital (UW-SCH)
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
M
Matthew Harting, MD, MS, FACS
CONTACT
A
Ashley Ebanks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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