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

DE Nemours/杜邦儿童医院 IDeA 国家儿科临床试验网络网站

• 批准号: 10242199
• 负责人: Judith L Ross
• 金额: $ 39.85万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10242199
• 关键词: Address; Admission activity; African American; Area; Asthma; Biomedical Research; Centers of Research Excellence; Child; Child Health; Childhood; Clinic; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Community Practice; Competence; Computerized Medical Record; Data; Database Management Systems; Delaware; Development; Discipline of obstetrics; Disease; Doctor of Medicine; Family Physicians; Fostering; Good Clinical Practice; Health; Hispanics; Hospitals; Human; Infant; Infrastructure; Institutional Review Boards; Life; Medicaid; Medical; Mission; Neonatal Abstinence Syndrome; Network-based; Obesity; Outcome; Outcomes Research; Patient Care; Patient Recruitments; Pediatric Hospitals; Pediatric Research; Pediatrics; Population; Poverty; Poverty Areas; Premature Infant; Premature Mortality; Primary Health Care; Principal Investigator; Procedures; Process; Public Health; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Rural; Rural Population; Scientist; Site; System; Talents; Textiles; Translational Research; Underserved Population; United States National Institutes of Health; Visit; Work; base; clinical trial implementation; community engagement; design; experience; high standard; implementation facilitation; improved; interest; neurodevelopment; novel; operation; pediatric patients; postnatal; programs; racial and ethnic; racial diversity; recruit; rural African American; rural area; rural underrepresented; rural underserved; web site

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

首席研究员/项目总监（最后、第一、中间）：Ross, Judith, M.D. 项目概要/摘要 特拉华内穆尔杜邦儿童医院的总体使命 IDeA 州儿科临床 试验网络站点（DE-Nemours/AIDHC ISPCTN 站点）旨在促进精心设计的实施 儿科临床试验，招募服务不足/农村儿童参与这些临床试验，并加强 特拉华州 IDeA 州的儿科临床试验能力。 DE 的婴儿早产率特别高 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。机会和 儿科临床进步的潜在影响对 DE 来说是显着的，其人口（约 100 万）是 美国人口、城乡公民比例和民族/种族多样性的缩影。它有一个 大型儿童医院（AIDHC 占 DE 儿科入院人数的 90% 以上），一家大型产科医院 （克里斯蒂安娜医院的 DE 分娩量超过 80%，每年约 7000 例），以及全州综合儿科初级保健 网络（19 个社区实践）。在此续订应用程序中，我们展示了我们在创建和 维持合作临床试验，解决战略性健康问题并克服纳入的障碍 居住在特拉华州农村或贫困地区的儿童。 DE ISPCTN 网站将继续利用关键 资源包括 1) 19 个基于 DE 儿科和初级保健实践的网络，覆盖超过 65,000 人 儿童（农村地区 23%，贫困地区 19%，医疗补助 52%），2) 获得历来代表性不足的机会 特拉华州的儿科人口，包括农村人口、非裔美国人和西班牙裔/拉丁裔人口，以及 3) 稳健 社区参与计划，例如 Nemours 儿童健康网站 KidsHealth，这是最 访问儿科健康网站（每天 100 万次点击）。我们拥有人才，拥有丰富的临床经验 研究团队（PI、Co-Is、初级和高级研究人员、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）。内穆尔/ AIDHC 在临床试验中全系统使用电子病历 (EPIC) 方面拥有超过 15 年的经验 研究。这些因素可以在当前的 ISPCTN 临床试验中实现高效的招募和保留， 覆盖该州农村和服务不足的儿童。 DE 网站将继续与强大的 DE IDeA 发挥协同作用 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 参与环境对儿童健康结果影响（ECHO）重点领域的临床试验 计划包括上/下呼吸道疾病、肥胖、产前/围产期/产后结果以及神经发育- ment。 DE 站点将继续与 ISPCTN 数据协调和运营中心密切合作 临床试验的开发和实施，将与整个 ECHO 计划和 NIH 合作， 并将扩大吸引贫困地区农村/服务不足人口的能力。提供这种专业知识和基础设施 该结构将增加旨在改善德国和美国公共卫生的尖端临床试验研究。 PHS 398/2590（修订版 05/01）页 _______ 继续格式页