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Clinical Trial 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, mortality, and/or oxygenation in CDH newborns and to establish the cost-effectiveness of deimplementing 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.

Clinical Trial 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 the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05213676
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact Matthew Harting, MD, MS, FACS
Phone (713) 500-7398
Status Not yet recruiting
Phase Phase 4
Start date January 1, 2023
Completion date January 30, 2028

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