RecruitingCongenital Diaphragmatic Hernia

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

Eligible age

0–0.1 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: The University of Texas Health Science Center, Houston

You may qualify if…

✓ 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

You may not qualify if…

✕ 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