Status:
NOT_YET_RECRUITING
Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to Determine if deimplementation of iNO in the post-natal resuscitation/stabilization phase affects the composite outcome of ECLS use and/or mortality, as well as ECLS use...
Detailed Description
In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05213676
Start Date
January 1 2025
End Date
December 31 2030
Last Update
June 29 2023
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030