UTHealth Houston researchers will serve as the principal investigators of the data coordinating center on an $11.4 million, groundbreaking clinical trial studying the efficacy of inhaled nitric oxide (iNO) in treating newborns with congenital diaphragmatic hernia (CDH). The study aims to evaluate the discontinuation of iNO during postnatal resuscitation and stabilization, working in collaboration with 19 institutions across the United States.
Funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, the study will investigate differences in the combined outcome of life support use on mortality among newborns. Researchers also will assess the cost-effectiveness of iNO and its impact on patient care and future practice.
CDH is a rare condition occurring in one to four per 10,000 births (1). The condition occurs when the diaphragm of the fetus does not fully develop, leaving a hole between the abdomen and chest. The trial will analyze the de-implementation of the current, common practice of iNO for fetuses with CDH.
“This will be a landmark trial where we investigate a specific therapy, factors driving clinician behaviors, and the economic implications for neonates with a very complex congenital anomaly,” said associate professor of pediatric surgery, Matthew T. Harting, MD, MS, a co-PI on the trial. “This team effort combines the strengths of McGovern Medical School, such as clinical care and an established, multicenter, collaborative study group, with the strengths of the School of Public Health, including clinical trial management and data coordination.”