NICHD Cooperative Multicenter Neonatal Research Network - Utah Center

项目摘要/摘要 这项申请的目标是犹他大学临床中心实现更新为研究网站在 2023-2030年新生儿研究网络(NRN)。犹他中心是NRN的积极参与者，拥有 在患者招募、NRN委员会活动以及参与设计和提交方面有良好的记录 过去和正在进行的几个NRN研究方案。此外，犹他州中心继续积极 参与几个大型、非NRN、多中心随机试验。目前的提案包括将重点放在 提高严密性和可重复性，允许非网络调查人员提交建议和参与 网络研究，加强数据共享，增加被研究人群的多样性。犹他州中心 首席研究员Robin Ohls博士是NHLBI资助的NRN Darbe研究的负责人，也是 Darbe-儿童5年跟踪建议。她过去和现在都参与了开发、设计、 撰写手稿，并作为PI和指导委员会成员监督许多NRN试验。候补PI， Mariana Baserga博士是Darbe和Open Network指导委员会的活跃成员，也是Site PI 用于一些开创性的非NRN试验。我们的合作伙伴蒂姆·巴尔博士与IHC和 并将在我们的两个IHC站点领导研究和NRN活动。我们的五人学习网络 网站，我们与犹他州母婴医学单位(MFMU)网络的合作，以及我们经验丰富的 研究基础设施使我们的中心成为唯一有资格进行NRN试验的机构。的具体优势 犹他州中心包括1)在多中心的设计、实施和管理方面的成熟专业知识 随机试验；2)过去对20多项大型随机试验的富有成效的合作贡献 NRN内外的十年；3)过去和现在在NRN内进行的合作研究 犹他州大学和山间医疗联盟；4)与犹他州进行富有成效的研究合作 MFMU的站点和教职员工；5)犹他州中心新生儿随访计划经过证明的记录超过90% 当前NRN研究和最近的非NRN多中心试验的随访率；6)来自 犹他大学健康科学中心和山间医疗保健的高级领导层， 包括所有参与医院的NICU和MFMU地点的医务主任。在…的领导下 Ohls博士，犹他大学已经建立了作为临床试验地点的生产力。一项既定的研究 基础设施、强大的新生儿跟踪计划以及跨广泛社区的协作活动 是支持犹他州中心更新为新生儿研究网络网站的主要因素。

PROJECT SUMMARY/ABSTRACT The goal of this application is for the University of Utah Clinical Center to achieve renewal as a research site in the 2023-2030 Neonatal Research Network (NRN). The Utah Center is an active participant in the NRN with a strong track record in patient recruitment, NRN committee activities, and involvement in design and submission of several past and on-going NRN study protocols. In addition, the Utah Center has continued to actively participate in several large, non-NRN, multi-center randomized trials. The current proposal includes a focus on enhancing rigor and reproducibility, allowing non-network investigators to submit proposals and participate in Network studies, enhancing data sharing, and increasing diversity in populations studied. The Utah Center Principal Investigator, Dr. Robin Ohls, leads the NHLBI-funded NRN Darbe Study, and is a multi-PI on the Darbe-KIDS 5-year follow up proposal. She has past and on-going participation in development, design, manuscript writing, and oversight as PI and steering committee member for many NRN trials. The alternate PI, Dr. Mariana Baserga, is an active member of the Darbe and Open Network Steering Committees, and a site PI for a number of seminal, non-NRN trials. Our co-PI, Dr. Tim Bahr, has joint appointments with IHC and the University of Utah, and will lead studies and NRN activities at two of our IHC sites. Our network of five study sites, our collaboration with the Utah Maternal-Fetal Medicine Unit (MFMU) Network, and our experienced research infrastructure makes our Center uniquely qualified to carry out NRN trials. Specific strengths of the Utah Center includes 1) established expertise in design, implementation and management of multi-center randomized trials; 2) productive collaborative contributions to over 20 large randomized trials over the past decade both within and outside the NRN; 3) past and current collaborative research studies within the University of Utah and Intermountain Healthcare consortium; 4) productive research collaboration with Utah MFMU sites and faculty; 5) the Utah Center Neonatal Follow-Up Program’s proven track record with over 90% follow-up rates for current NRN studies and recent non-NRN multi-center trials; 6) documented support from senior leadership across both the University of Utah Health Sciences Center and Intermountain Healthcare, including Medical Directors of the NICUs and MFMU sites at all participating hospitals. With the leadership of Dr. Ohls, the University of Utah has established productivity as a clinical trial site. An established research infrastructure, strong Neonatal Follow-Up program, and collaborative activities across a widespread community are major factors supporting renewal of the Utah Center as a Neonatal Research Network site.