drugset / Trial / NCT05213676
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Phase 4
Recruiting
600 enrolled
The University of Texas Health Science Center, Houston
Boston Children's Hospital · collabChildren's Hospital Colorado · collabChildren's Hospital of Orange County · collabEmory University & Children's Healthcare of Atlanta (CHOA) · collabIndiana University & Riley Children's Hospital (IU-RiCH) · collabMedical University of South Carolina Children's Health (MUSC) · collabNorton Children's Hospital · collabRady Children's Hospital, San Diego · collabRandall Children's Hospital-Portland (RCH) · collabStanford University & Lucile Packard Children's Hospital (Stanford-LPCH) · collabUniversity of Alabama & Children's Hospital of Alabama (UAB-CoA) · collabUniversity of Arkansas · collabUniversity of Michigan & CS Mott Children's Hospital (UM-CSMott) · collabUniversity of Southern California & Children's Hospital Los Angeles (USC-CHLA) · collabUniversity of Tennessee & LeBonheur Children's Hospital (UT-LBCH) · collabUniversity of Utah & Primary Children's Hospital (Utah-PCH) · collabUniversity of Washington & Seattle Children's Hospital (UW-SCH) · collabVanderbilt University Medical Center · collab
RandomizedCrossoverOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-11-01
- Primary completion
- 2030-10-31
- Completion
- 2031-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nitric Oxide | Other / unclassified | — | Inhaled |