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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05213676). StuddyBuddy aggregates publicly available trial information.