The DE Nemours/duPont Hospital for Children IDeA States Pediatric Clinical Trials Network Site

首席调查员/项目主任(最后、第一、中间)：罗斯、朱迪思、医学博士 项目摘要/摘要 特拉华州内穆尔·杜邦儿童医院的总体使命IDEA州儿科临床 试验网络网站(DE-Nemour/AIDHC ISPCTN网站)是为促进实施精心设计的 儿科临床试验，招募服务不足/农村儿童参加这些临床试验，并加强 儿科临床试验能力处于理想状态，DE。DEE的婴儿早产率非常高， 死亡率、哮喘、肥胖和出生时患有新生儿阿片戒断综合征的婴儿。机遇和机遇 儿科临床进展的潜在影响在DE是显著的，其人口(约100万)是 在人口统计学上，城市和农村公民比例和种族/种族多样性是美国的缩影。它有一个 主要的儿童医院(AIDHC和90%的DE儿科住院)，一家主要的产科医院 (克里斯蒂娜医院和GT；80%的DE分娩，约7000/年)，以及全州综合儿科初级保健 网络(19个社区实践)。在此续订申请中，我们展示了我们在创建和 持续开展协作临床试验，解决战略性健康问题并克服纳入的障碍 居住在德州农村或贫困地区的儿童。DE ISPCTN站点将继续利用密钥 资源包括1)19个DE儿科和以初级保健实践为基础的网络，覆盖超过65,000个 儿童(23%在农村地区，19%在贫困地区，52%在医疗补助计划中)，2)获得历史上人数不足的机会 DE的儿科人口，包括农村、非裔美国人和西班牙裔/拉丁裔人口，以及3)稳健 社区参与项目，如Nemour儿童健康网站KidsHealth，最- 访问儿科健康网站(每天100万次点击)。我们有人才，有非常丰富的临床经验 研究团队(PI、Co-IS、初级和高级调查人员、协调员、数据录入人员)和临床 研究基础设施(临床研究中心、IRB流程、标准操作程序)。线虫/ AIDHC在临床试验中全系统使用电子病历(EPIC)方面拥有15年的经验 研究。这些因素允许在当前的ISPCTN临床试验中高效地招募和保留 接触到该州农村和服务不足的儿童。DE网站将继续与Robust DE Idea协同工作 国家资源。此外，我们描述了我们在社区参与/患者招募方面的优势， 临床医生和研究人员的参与以及临床研究基础设施能力建设使我们能够 在环境对儿童健康结果的影响(ECHO)的重点领域进行临床试验 项目包括上/下呼吸道紊乱，肥胖，产前/围产期/产后结局，以及神经发育- 门槛。远程教育站点将继续与ISPCTN数据协调和业务中心密切合作。 临床试验的开发和实施，将与整个ECHO计划和NIH合作， 并将扩大能力，使DE的农村/未得到充分服务的人口参与进来。提供这方面的专业知识，并在以下方面- 结构将增加旨在改善DE和美国公共健康的尖端临床试验研究。 PHS 398/2590(05/01版)第_续格式页

Principal Investigator/Program Director (Last, first, middle): Ross, Judith, M.D. Project Summary/Abstract The overall mission of the Delaware Nemours DuPont Hospital for Children IDeA States Pediatric Clinical Trials Network site (DE-Nemours/AIDHC ISPCTN site) is to facilitate implementation of well-designed pediatric clinical trials, recruit underserved/rural children to participate in these clinical trials, and enhance pediatric clinical trial capacity within the IDeA state, DE. DE has notably high rates of infant prematurity and mortality, asthma, obesity, and infants born with neonatal opioid withdrawal syndrome. The opportunity and the potential impact of pediatric clinical advances are significant in DE, whose population (~1 million) serves as a microcosm of the US, demographically, in urban-to-rural citizen ratio and ethnic/racial diversity. It has one major children’s hospital (AIDHC with >90% of DE pediatric admissions), one major obstetric hospital (Christiana Hospital with >80% of DE deliveries, ~7000/year), and a statewide integrated pediatric primary care network (19 community practices). In this renewal application, we demonstrate our progress in creating and sustaining collaborative clinical trials that address strategic health issues and overcome barriers to inclusion of children residing in rural or impoverished areas of DE. The DE ISPCTN site will continue to harness key resources including 1) 19 DE pediatrics and primary care practice-based networks that cover over 65,000 children (23% in rural areas, 19% in poverty and 52% Medicaid), 2) access to historically underrepresented pediatric populations in DE, including rural, African-American and Hispanic/Latino populations, and 3) robust community engagement programs such as the Nemours children's health website KidsHealth, the most- visited pediatric health site (1 million hits/day). We have the human talent, with highly experienced clinical research teams (PI, Co-Is, junior and senior investigators, coordinators, data entry staff) and the clinical research infrastructure (Clinical research center, IRB processes, standard operating procedures). Nemours/ AIDHC has >15 years’ experience with system-wide use of electronic medical records (EPIC) in clinical trials research. These factors allow for highly effective recruitment and retention in current ISPCTN clinical trials and reach rural and underserved children in the state. The DE site will continue to synergize with robust DE IDeA state resources. Further, we delineate how our strengths in community engagement/patient recruitment, clinician and researcher engagement, and clinical research infrastructure capacity building have allowed us to engage in clinical trials in the focus areas in the Environmental influences on Child Health Outcomes (ECHO) Program including Upper/lower airway disorders, Obesity, Pre-/peri-/postnatal outcomes, and Neurodevelop- ment. The DE site will continue to work closely with the ISPCTN Data Coordinating and Operations Center in development and implementation of clinical trials, will collaborate with the overall ECHO program and the NIH, and will expand capacity to engage rural/underserved populations in DE. Provision of this expertise and infra- structure will increase cutting edge clinical trial research aimed at improving public health in DE and the US. PHS 398/2590 (Rev. 05/01) Page _______ Continuation Format Page