North Carolina Clinical Center

摘要 杜克大学新生儿学部热心递交续期申请 参加尤尼斯·肯尼迪·施莱弗NICHD赞助的多中心合作新生儿 研究网络(NRN)。杜克大学正在与该大学合作提交申请 北卡罗来纳州的教堂山(UNC)和东卡罗来纳大学(ECU)，作为北卡罗来纳州 NRN临床中心(NCCC)。支持NRN Duke和NCCC的目标是：1) 招募人口统计学上不同的患者参加NRN研究，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，成为新生儿临床研究的领先者。 为了支持这三个目标，杜克大学增加了卫星站点，以增加符合条件的患者人数和 拓宽NRN互动的机会。Duke是第一个在NRN网站上添加独立的 2008年北卡罗来纳大学加入杜克大学时，该校是一所学术机构。位于北卡罗来纳州格林维尔的ECU加入了 2018年。NCCC在最近完成的和 目前正在招收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 总有效率为84%。北卡罗来纳州北卡罗来纳大学的PI领导着NRN PDA试验。在上一个周期中，超过20个 NCCC调查人员共同撰写了52篇NRN出版物，其中包括9篇第一作者论文。 NCCC网站将继续最大限度地增加注册努力，并保持NRN的高跟随率 学习。NCCC领导层将为NRN提供重要的临床试验经验，并将 引入创新概念，如综合结果的全球排名评分和新研究 设计如主方案，以促进试验的有效进行和试验之间的比较。 我们将启动协议孵化器系统，以支持早期职业生涯中的协议开发 调查人员。此外，我们将为验证新技术的研究带来概念，包括 光学相干断层扫描用于视网膜成像的测试及其与视力的关系 以及神经发育结果。杜克大学、北卡罗来纳大学和ECU全力支持NCCC正在进行的 对NRN的协作承诺。我们坚信，我们的NRN互动已经改善 在我们的三个机构和我们全州照顾婴儿。我们有很强的动力去 改善婴儿结局，支持下一代临床医生的发展 通过与NRN合作，新生儿科的科学家们。

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.