One Center, Two States

Children'S Mercy Hosp (Kansas City, Mo), Kansas City MO

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): This application, submitted in response to RFA HD 16-020, provides a compelling argument for retaining our clinical site, comprised of Children's Mercy Hospital (CMH), Truman Medical Center (TMC), the University of Missouri-Kansas City School of Medicine (UMKC) and the Kansas University Medical Center (KUMC) in the 2016-2021 version of the Eunice Kennedy Shriver NICHD Neonatal Research Network (NRN). Since 2011, our Center has grown by adding the Kansas University Medical Center (KUMC) as a satellite site. Our Center brings experience and expertise in performing Phase III trials, prospective cohort and retrospective study designs. Our first four years of participation in the NRN, coupled with affiliations with the Vermont Oxford Network (VON), and with the Children's Hospital Neonatal Consortium (CHNC) database and outcomes programs, has provided extraordinary experience with multicenter trials and outcomes evaluations. Our site now houses local research centers that bring extraordinary expertise in disciplines highly relevant to the need for modernization of clinical trials. The overall GOAL of our unified Center is to improve outcomes, measured by short term and long-term reduction in mortality and morbidity, of high-risk preterm and term infants. We demonstrate in the application our ability to manage comprehensive and long-term follow-up programs skillfully. We provide evidence of studies conducted successfully in an ethnically diverse patient population. The first SPECIFIC AIM of this application is to respond to the RFA with data showing that our center met and often exceeded the expectations of the NRN established during the 2011-2016 cycle. Additionally we will describe the research intensive assets of CMH and their personnel that could contribute to the 2016-2021 version of the Network. Through the concepts of phenotype/genotype correlations and study stratification using contemporary tools developed or optimized in our NRN clinical center, we are able to harness and leverage our local expertise in pharmacogenomics, panomics, and study design execution, and follow-up to reduce suffering and death in high-risk infants. Thus, our site's goal coincides with the larger goal of the NRN: to conduct multi-center clinical trials to establish the safety and efficacy of potentially important new therapies and management strategies for at-risk infants.