Pediatric Heart Network: Medical University of South Carolina

PROJECT SUMMARY The Children's Heart Program of South Carolina is a statewide consortium of pediatric cardiologists who provide pediatric cardiac care for >90% of the 5.1 million residents in the state. The Pediatric Heart Program at MUSC performs all of the cardiac surgery and interventional cardiac catheterizations for this racially and ethnically

diverse patient population. Clinical outcomes are consistently among the best in the country. MUSC has all the critical elements to be a successful contributor in the Pediatric Heart Network (PHN): adequate patient volume, established clinical research infrastructure, a track record of outstanding subject enrollment, and a dedication

to hypothesis driven research. These elements have allowed our site to be a highly successful and administratively active participant in the PHN and one of only 5 core centers to be continuously funded since its inception in 2001 The combined resources of patient volume, research infrastructure and dedication have

enabled MUSC to be among the top subject enrollers in the PHN. During this period, we have introduced numerous trainees and junior faculty to the PHN and mentored them toward successful careers in clinical investigation. MUSC faculty, nurse practitioners, and ancillary staff have participated as Pls in a wide variety of

multicenter studies, including many NIH-funded trials, analyses of clinical registry data, and industry sponsored/FDA regulated trials. Our nationally recognized team of investigators have an extensive track record of extramural funding, national presentations, publications in leading journals, and an extensive network of

diverse collaborators across North America. MUSC faculty also currently direct numerous local clinical research protocols. In this application, we have submitted a concept proposal for a novel and highly impactful study of the impact of environmental neurotoxins on early clinical and 18-month neurodevelopmental outcomes of

neonates undergoing cardiac surgery. The aims and hypotheses in this proposal are supported by strong pilot data generated by our research team in collaboration with external investigators that demonstrate significant exposure to cyclohexanone, phthalates, and volatile organic compounds in neonates undergoing cardiac

surgery. These exposures occur both in the hospital setting and/or the home environment and have the potential to explain some of the disparate outcomes observed in this patient population. Our preliminary work has established the feasibility of the project and the directionality of the findings in terms of impact on patient

outcomes. Given the prior success of PHN centers in enrolling neonates undergoing cardiac surgery in clinical trials, the project is likely to be completed in a timely fashion and lead to actionable changes in patient care.