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De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

RecruitingPhase 4Ages 0 Months - 1 MonthAllThe University of Texas Health Science Center, Ho…
NCT05213676 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Inhaled Nitric Oxide (iNO) use
  • De-implementation of Inhaled Nitric Oxide (iNO) use
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Where

19 sites
University of Alabama & Children's Hospital of Alabama (UAB-CoA)
Birmingham, United States
University of Arkansas & Arkansas Children's Hospital (UA-ACH)
Little Rock, United States
University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
Irvine, United States
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Los Angeles, United States
Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
Palo Alto, United States
University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
San Diego, United States
University of Colorado & Children's Hospital of Colorado (CU-CHC)
Aurora, United States
Emory University & Children's Healthcare of Atlanta (CHOA)
Atlanta, United States

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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