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: 10475075
• 负责人: Robert E Akins
• 金额: $ 39.5万
• 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/10475075
• 关键词: Address; Admission activity; African American population; 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; Hispanic; Hispanic Populations; Hospitals; Human; Infant; Infrastructure; Institutional Review Boards; Latino Population; 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/计划主任（最后，第一，中间）：罗斯，朱迪思，医学博士 项目摘要/摘要 特拉华州杜邦杜邦医院的整体任务 试验网站（De-Nemours/AIDHC ISPCTN站点）将托管精心设计的实施 小儿临床试验，招募服务不足/农村儿童参加这些临床试验，并增强 构想状态内的小儿临床试验能力。 DE的婴儿早产率明显很高， 死亡率，哮喘，肥胖和患有新生儿阿片类药物戒断综合征的婴儿。机会和 小儿临床进展的潜在影响在DE中显着，DE的人口（约100万）是 在人口统计学上，以城市与农村公民比例和种族/种族多样性为单位，美国的缩影。它有一个 主要儿童医院（AIDHC> 90％的DE儿科入院），一家主要产科医院 （克里斯蒂安娜（Christiana 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 维持协作性临床试验，以解决战略健康问题并克服包含的障碍 居住在DE的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个儿科和基于初级保健实践的网络，覆盖了65,000多个 儿童（农村地区23％，贫困19％，医疗补助为52％），2）历史上代表性不足的机会 DE的儿科种群，包括粗糙，非裔美国人和西班牙裔/拉丁裔人口，3）强大 社区参与计划，例如Nemours儿童健康网站Kidshealth，最多的社区参与计划 访问的小儿健康网站（每天100万次）。我们有人才，拥有经验丰富的临床 研究团队（PI，Co-IS，初级和高级研究人员，协调员，数据输入人员）和临床 研究基础设施（临床研究中心，IRB过程，标准操作程序）。 nemours/ AIDHC在临床试验中具有> 15年的全系统使用电子病历（EPIC）的经验 研究。这些因素允许在当前ISPCTN临床试验中进行高效的招聘和保留率，并 到达该州的农村和服务不足的儿童。 DE网站将继续与强大的DE IDEA合成 国家资源。此外，我们描述了我们在社区参与/患者招聘方面的优势， 临床和研究人员参与以及临床研究基础设施能力建设使我们得以 在环境影响儿童健康结果的焦点区域进行临床试验（ECHO） 程序包括上/下气道疾病，肥胖，/周期/产后结局和神经发育 精神。 DE网站将继续与ISPCTN数据协调和操作中心紧密合作 临床试验的开发和实施将与整体回声计划和NIH合作， 并将扩大在DE中吸引农村/服务不足人群的能力。提供此专业知识和基础 结构将增加临时试验研究，旨在改善DE和美国的公共卫生。 PHS 398/2590（修订版05/01）页_______延续格式页面