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

BG

Brian Gray, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 0 Months - 1 Month Gender: All Genders Phase: N/A 1 Locations

Brief Description

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

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.

PRIMARY OBJECTIVES:

  • Number of participants that require Extracorporeal Life Support (ECLS) and/or that die prior to discharge

SECONDARY OBJECTIVES:

  • Number of participants that require Extracorporeal Life Support (ECLS) prior to discharge
  • Number of participants that die prior to discharge
  • Change in oxygenation
  • Change in oxygenation
  • Total cost of initial inpatient care from birth through hospital discharge, per center

Eligibility of study

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.