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NCT05213676
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Conditions: Congenital Diaphragmatic Hernia
Sex: All
Ages: 0 Months – 1 Month
Healthy volunteers: No
Phase: PHASE4
Enrollment: 900
Sponsor: The University of Texas Health Science Center, Houston
Location: University of Alabama & Children's Hospital of Alabama (UAB-CoA) Birmingham Alabama
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 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
Source: ClinicalTrials.gov (NCT05213676). StuddyBuddy aggregates publicly available trial information.