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

项目摘要 密西西比大学医学中心（UMMC）、密西西比儿童中心和UMMC医学部 儿科正在寻求继续成为ECHO机构发展奖（IDEA）国家的一个网站 儿科临床试验网络-2（ISPCTN-2）。我们的站点，密西西比ECHO ISPCTN-2（MS-CTN 2） 在2016年福鼎市初步ISPCTN的实施方面取得了相当大的进展，大大扩展了我们的 机构基础设施和开放2儿科试验：肥胖儿童的维生素D补充剂- 相关哮喘和未研究药物的药代动力学给药儿童按照标准 护理研究。 UMMC网站的总体目标是： 1.建立在以前的网络成功，并进一步加强我们的UMMC儿科临床研究团队， 可靠地进行网络儿科临床试验; 2.促进在农村和服务不足的社区参与儿科临床试验; 3.为NIH的ECHO计划做出实质性贡献，该计划为未来几代人的健康提供信息。 子女;及 4. Brochure教师，工作人员和机构能力建设基础设施，用于参与网络试验。 我们的ISPCTN网站通过增加儿科基础设施，提高了儿科试验的准备程度 在初始融资周期内提供支持。通过ISPCTN，我们网站的容量大幅增长 提供培训，与其他网站合作，并与密西西比中心合作， 临床和转化研究（MCCTR）。我们的团队已经获得了试验招募的经验，并将 在ISPCTN-2期间继续建设农村社区的征聘能力。UMMC的研究中心研究者 为ISPCTN计划做出了重要贡献，领导工作组并开发儿科 审判通过在ISPCTN内建立的合作，学术工作产品得到了发展。 通过MS-CTN 2，我们的研究中心将继续全面参与ECHO ISPCTN试验，包括那些寻求 改善对宫内接触阿片类药物的婴儿的护理。通过ISPCTN-2，我们希望开发、实施和 完成3项针对ECHO疾病优先级的临床试验。此外，我们的初级教师将开发一个 IPSCTN-2多中心试验的研究方案。最后，我们的网站正在领导一项提案， 已经得到经验验证的心理社会干预，将这种干预扩展到高危婴儿， 这是对现有干预措施的一种新的延伸。 我们的MS-CTN2站点有望成为农村和医学领域的主要儿科研究中心。 南方腹地服务不足的社区在持续的支持下，我们的网站将提供来自以下方面的新数据： 扩展到农村社区的试验，从而增加儿科试验研究的普遍性。

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.