North Carolina Clinical Center

北卡罗来纳州临床中心

基本信息

批准号：
10682085
负责人：
CHARLES Michael COTTEN
金额：
$ 37.66万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-05-01 至 2030-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10682085
关键词：
Active Sites African American Candidiasis Childhood Classification Clinical Clinical Research Clinical Trials Clinical Trials Design Collaborations Common Data Element Communities DNA Library Databases Development Eligibility Determination Enrollment Faculty Follow-Up Studies Fostering Health Hispanic Incubators Infant Infant Care Infant Health Inositol Institution Journals Lead Leadership Link Low Birth Weight Infant Manuscripts Maternal Health Medical center Mission Multicenter Neonatal Research Network Multicenter Trials National Institute of Child Health and Human Development Neonatology Neurodevelopmental Impairment Newborn Infant North Carolina Not Hispanic or Latino Observational Study Optical Coherence Tomography Outcome Outcome Assessment Paper Patients Perinatal Phase Phototherapy Population Heterogeneity Premature Infant Process Protocols documentation Psychologist Publications Reporting Research Research Design Research Personnel Resources Review Committee Scientist Site Staff Development Support Groups System Testing Transfusion Universities Update Visual Acuity Vital Statistics career career development clinical center clinical practice clinical research site collaborative approach community engaged research design environmental enrichment for laboratory animals experience follow-up health equity high risk imaging biomarker improved improved outcome infant outcome innovation interdisciplinary approach mortality risk neuroimaging marker new technology next generation novel operation participant enrollment patient population perinatal services premature protocol development retinal imaging trial design

项目摘要

Abstract The Duke University Division of Neonatology enthusiastically submits this renewal application for participation in the Eunice Kennedy Shriver NICHD-sponsored Cooperative Multicenter Neonatal Research Network (NRN). Duke is submitting the application in collaboration with the University of North Carolina at Chapel Hill (UNC) and East Carolina University (ECU), as the North Carolina Clinical Center (NCCC) for the NRN. To support the NRN Duke's and the NCCC's aims are to: 1) enroll demographically diverse patients in NRN studies and achieve high follow-up rates, 2) develop innovative trial designs and concepts for NRN studies, and 3) develop the next generation of clinical research leaders in Neonatology via interactions with the NRN. In support of the 3 aims Duke has added satellite sites to increase eligible patient populations and broaden opportunities for NRN interactions. Duke was the first NRN site to add an independent academic institution when the UNC joined Duke in 2008. ECU, located in Greenville, NC, joined in 2018. The NCCC has been among the top 5 enrolling sites among recently completed and currently enrolling NRN trials. Follow-up for over 250 infants enrolled in clinical trials has been over 95%. Follow-up for infants in the NRN observational trials is 86%, slightly above the NRN overall rate of 84%. The NCCC UNC site PI leads the NRN PDA trial. In the last cycle, over 20 NCCC investigators co-authored 52 NRN publications, including 9 first-author papers. NCCC sites will continue maximizing enrollment efforts and maintain high follow-up rates for NRN studies. The NCCC leadership will provide significant clinical trial experience to the NRN, and will bring innovative concepts such as a Global Rank Score for composite outcomes and new study designs such as master protocols to promote efficient conduct of and comparisons between trials. We will initiate a Protocol Incubator system to support protocol development by early career investigators. In addition, we will bring concepts for studies to validate new technology, including testing of optical coherence tomography for retinal imaging and associations with visual acuity and neurodevelopmental outcomes. Duke, UNC, and ECU fully support the NCCC's ongoing collaborative commitment to the NRN. We firmly believe that our NRN interactions have improved care of infants in our three institutions, and throughout our State. We are highly motivated to improve outcomes of infants, and support development of the next generation of clinician scientists in Neonatology, by working with the NRN.

抽象的杜克大学新生儿科热情地提交了这份续签申请参与尤尼斯·肯尼迪·施赖弗 (Eunice Kennedy Shriver) NICHD 赞助的合作多中心新生儿项目研究网络（NRN）。杜克大学正在与大学合作提交申请北卡罗来纳大学教堂山分校 (UNC) 和东卡罗来纳大学 (ECU) NRN 临床中心 (NCCC)。支持 NRN Duke 和 NCCC 的目标是：1) 在 NRN 研究中招募人口统计多样化的患者并实现高随访率，2) 为 NRN 研究开发创新的试验设计和概念，以及 3) 开发下一代通过与 NRN 的互动，培养新生儿学临床研究领导者。为了支持这 3 个目标，杜克大学增加了卫星站点，以增加符合条件的患者群体和扩大 NRN 互动的机会。杜克大学是第一个添加独立网络的 NRN 站点 2008 年 UNC 加入杜克大学时的学术机构。位于北卡罗来纳州格林维尔的 ECU 加入 2018 年，NCCC 已跻身于近期竣工和竣工的前 5 名招生站点之列。目前正在招募 NRN 试验。对参加临床试验的 250 多名婴儿进行了随访超过95%。 NRN 观察性试验中婴儿的随访率为 86%，略高于 NRN 总体合格率84%。 NCCC UNC 站点 PI 领导 NRN PDA 试验。在上一个周期中，超过20 NCCC 研究人员共同撰写了 52 篇 NRN 出版物，其中包括 9 篇第一作者论文。 NCCC 站点将继续最大限度地加大注册力度并保持 NRN 的高随访率研究。 NCCC 领导层将为 NRN 提供重要的临床试验经验，并将带来创新概念，例如综合结果的全球排名分数和新研究诸如主协议之类的设计，以促进试验的有效进行和比较。我们将启动一个协议孵化器系统来支持早期职业生涯的协议开发调查人员。此外，我们还将带来验证新技术的研究概念，包括光学相干断层扫描的视网膜成像测试及其与视力的关系和神经发育结果。杜克大学、北卡罗来纳大学和 ECU 全力支持 NCCC 的持续发展对 NRN 的合作承诺。我们坚信我们的 NRN 互动有所改善我们三个机构以及整个州的婴儿护理。我们充满动力改善婴儿的结局，支持下一代临床医生的发展新生儿学科学家与 NRN 合作。