Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05213676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-29
First Post:
2022-01-27
Brief Title:
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
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to Determine if deimplementation of iNO in the post-natal resuscitationstabilization phase affects the composite outcome of ECLS use andor mortality as well as ECLS use mortality andor oxygenation in CDH newborns and to establish the cost-effectiveness of deimplementing iNO as a therapy in the postnatal resuscitationstabilization phase of CDH management which will be assessed as the incremental health system costs savings per prevented ECLS use andor death
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None