Study of Inhaled Nitric Oxide Use and Its Removal in Newborns with Congenital Diaphragmatic Hernia A Multi-center, Randomized Trial Comparing Standard Treatment to No iNO in the First Month of Life

What this Trial Is About

This research investigates the effects of stopping the use of inhaled nitric oxide iNO during the early resuscitation and stabilization phase after birth in newborns with congenital diaphragmatic hernia CDH. The study aims to see if this change affects the combined outcome of needing extracorporeal life support ECLS or death, as well as individual outcomes like ECLS use, mortality, and oxygen levels. Additionally, the study will assess whether stopping iNO in this phase is cost-effective by measuring health system savings per prevented ECLS use or death. The study uses a stepped-wedge crossover design across multiple centers. Initially, centers will use iNO following their usual protocols during the resuscitation period from birth through stabilization and surgical repair of CDH. Later, each center will switch to not using iNO in this initial phase. No other parts of the standard clinical care guidelines for CDH will be changed. The timing of these crossovers is randomized at the center level. Participants include newborns diagnosed with CDH who are either born at or transferred to participating centers within the first week of life. Throughout the study, researchers will monitor outcomes such as the number of infants needing ECLS or who die before discharge up to 12 months from birth, changes in oxygenation shortly after starting iNO, and the total costs of initial inpatient care. The study will also track safety and health outcomes during hospital stays and follow-up periods up to one year.

De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia