Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia

NCT05213676

RecruitingPhase 4

Sponsor: The University of Texas Health Science Center, Houston

Conditions: Congenital Diaphragmatic Hernia

Interventions: Inhaled Nitric Oxide (iNO) use, De-implementation of Inhaled Nitric Oxide (iNO) use

Countries: United States

The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing 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.

Eligibility overview

Sex: ALL

Age: 0 Months to 1 Month

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (19)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • Aurora, Colorado, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Portland, Oregon, United States
  • Charleston, South Carolina, United States
  • Memphis, Tennessee, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States