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: 10064475
• 负责人: Judith L Ross
• 金额: $ 40.67万
• 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/10064475
• 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; 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 implementation; design; experience; high standard; improved; interest; neurodevelopment; novel; operation; patient engagement; pediatric patients; postnatal; programs; racial and ethnic; racial diversity; recruit; rural African American; rural area; 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

主要研究者/项目负责人（最后，第一，中间）：Ross，Judith，医学博士 项目总结/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-Nemours/AIDHC ISPCTN网站）是为了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 儿科临床试验的能力在IDEA州，DE。DE的婴儿早产率明显较高， 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。的机遇和 儿科临床进展的潜在影响在DE中是显著的，其人口（约100万）是 从人口统计学上讲，美国是美国城乡人口比例和民族/种族多样性的缩影。它有一个 大型儿童医院（AIDHC，DE儿科入院率>90%），一家大型产科医院 （Christiana医院，DE分娩率>80%，约7000/年），以及全州综合儿科初级保健 网络（19个社区实践）。在此更新申请中，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，克服纳入的障碍， 居住在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DE儿科和基于初级保健实践的网络，覆盖65，000多人 儿童（23%在农村地区，19%在贫困和52%的医疗补助），2）获得历史上代表性不足 DE中的儿科人群，包括农村、非洲裔美国人和西班牙裔/拉丁裔人群，以及3）稳健 社区参与计划，如内穆尔儿童健康网站KidsHealth，最- 访问儿科保健网站（每天100万次点击）。我们拥有人才，具有丰富的临床经验， 研究团队（PI、Co-Is、初级和高级研究者、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、标准操作规程）。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 research.这些因素允许在当前的ISPCTN临床试验中高度有效地招募和保留， 帮助农村和服务不足的儿童。DE研究中心将继续与稳健的DE IDEA协同 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的能力建设，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 项目包括上/下呼吸道疾病、肥胖、产前/产后结局和神经发育- 我是说。DE网站将继续与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， 并将扩大吸引特拉华州农村/服务不足人口的能力。提供这种专门知识和基础设施， 该结构将增加旨在改善DE和美国公共卫生的尖端临床试验研究。 PHS 398/2590（修订版05/01）第__续格式页