Mississippi site (Mississippi ECHO ISPCTN-2 (MS-CTN2)

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PROJECT SUMMARY The University of Mississippi Medical Center (UMMC), Children’s of Mississippi, and the UMMC Department of Pediatrics are seeking to continue to be a site for the ECHO Institutional Development Award (IDeA) States Pediatric Clinical Trials Network-2 (ISPCTN-2). Our site, the Mississippi ECHO ISPCTN-2 (MS-CTN2) has made considerable progress with implementation of the initial ISPCTN fuding in 2016, greatly expanding our institutional infrastructure and opening 2 pediatric trials: Vitamin D Supplementation in Children with Obesity- Related Asthma and the Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care study. The UMMC site’s overarching objectives are: 1. Build upon previous Network success and further enhance of our UMMC pediatric clinical research team to reliably conduct Network pediatric clinical trials; 2. Promote engagement in pediatric clinical trials across largely rural and underserved communities; 3. Make substantive contributions to the NIH’s ECHO program that inform the health of future generations of children; and 4. Broaden faculty, staff, and institutional capacity-building infrastructure for engagement in Network trials. Our ISPCTN site has increased readiness for pediatric trials through increasing pediatric infrastructure supports during the initial funding cycle. The capacity of our site has grown considerably through ISPCTN provided trainings, collaborations with other sites, and institutional collaboration with the Mississippi Center for Clinical and Translational Research (MCCTR). Our team has gained experience in trial recruitment and will continue to build capacity for recruitment in rural communities during ISPCTN-2. Site investigators at UMMC have made important contributions to the ISPCTN program, leading working groups and developing a pediatric trial. Scholarly work products have grown through collaborations established within the ISPCTN. With MS-CTN2, our site will continue to be fully engaged with ECHO ISPCTN trials, including those that seek to improve care for infants exposed to opioids in utero. With ISPCTN-2 we expect to develop, implement and complete 3 clinical trials that address ECHO disease priorities. In addition, our junior faculty will develop a research protocol that informs an IPSCTN-2 multi-center trial. Finally, our site is leading a proposal to test an already empirically validated psychosocial intervention, extending this intervention to high risk infants and across rural communities, representing a novel extension to an existing intervention. Our MS-CTN2 site is poised to become a major pediatric research center in the rural and medically underserved communities of the deep South. With continued support our site will contribute new data from trials that extend into rural communities, thus increasing the generalizability from pediatric trials research.