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NCT05213676 | NOT YET RECRUITING | Congenital Diaphragmatic Hernia

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

Information provided by (Responsible Party):

Matthew T Harting

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, 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.

Condition or disease

Congenital Diaphragmatic Hernia

Intervention/treatment

Inhaled Nitric Oxide (iNO) use

De-implementation of Inhaled Nitric Oxide (iNO) use

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2029-12-31
Estimated Study Completion Date : 2030-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Months to 1 Month
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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

Location Details

NCT05213676

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030