NICHD Cooperative Multicenter Neonatal Research Network - Utah Center

 描述（由申请人提供）：本申请的具体目的是使犹他州大学临床中心成功进入NICHD新生儿研究网络（NRN），用于2016-2021周期。犹他州中心在2006-2011年期间曾是NRN的积极参与者，积极参与患者招募、NRN委员会活动，并参与设计和提交多项既往或正在进行的NRN研究方案。虽然目前不是一个活跃的NRN中心，但犹他州中心继续积极为几项正在进行的研究提供新生儿随访，包括6-7年的SUPPORT随访。犹他州中心继续积极参与几项大型、非NRN、多中心随机试验。主要研究者，布拉德利A博士。Yoder作为PI和/或指导委员会成员过去和正在参与许多非NRN试验的开发、设计手稿撰写和监督。目前的提案包括扩大犹他州新生儿重症监护病房（NICU）的数量;与过去20年来一直是犹他州母胎医学单位（MFMU）网络积极成员的中心保持一致。犹他州中心现在包括5个站点，拥有250张NICU床位，每年有超过4，000名NICU住院患者;占所有犹他州NICU护理的近90%，占所有ELGAN/ELBW婴儿的近100%。犹他州中心的具体优势包括：1）与大多数其他NRN中心不同的人口基础，包括相对较高的社会经济地位和高比例的非西班牙裔白人; 2）在多中心随机试验的设计、管理和分析方面建立了专业知识; 3）在过去十年中为超过15项大型随机试验做出了富有成效的合作贡献; 4）犹他州大学和Intermountain Healthcare联盟过去和当前的合作研究; 5）经验丰富的研究人员和支持基础设施，包括犹他州大学临床和转化科学中心、儿科药理学项目和妇女儿童研究所; 6）与犹他州MFMU站点和教师进行富有成效的研究合作; 7）现已整合到儿科系的增强型新生儿随访计划;以及8）来自犹他州健康科学大学和山间医疗保健大学的高级领导层的支持，包括所有参与医院的NICU和MFMU站点的医学主任。在Yoder博士的领导下，犹他州大学已经建立了作为临床试验地点的生产力。一个成熟的研究基础设施， 强大的新生儿随访计划和广泛的社区合作活动，加上非常成功的犹他州MFMU，是将犹他州中心选为NRN研究中心的主要因素。

 DESCRIPTION (provided by applicant): The Specific Aim of this application is for the University of Utah Clinical Center to achieve successful entry into the NICHD Neonatal Research Network (NRN) for the 2016-2021 cycle. The Utah Center was previously an active NRN participant during the 2006-2011 with strong participation in patient recruitment, NRN committee activities, and involvement in design and submission of several past or on-going NRN study protocols. Though currently not an active NRN Center, the Utah Center has continued to actively provide neonatal follow-up for several on-going studies, including 6-7 year follow-up for SUPPORT. The Utah Center has continued active participation in several large, non-NRN, multi-center randomized trials. The Principal Investigator, Dr. Bradley A. Yoder, has past and on-going participation in development, design manuscript writing, and oversight as PI and/or steering committee member for many of these non-NRN trials. The current proposal includes an expanded number of Utah Neonatal Intensive Care Unit (NICU) sites; in line with centers that have been active members of the Utah Maternal-Fetal Medicine Unit (MFMU) Network for the past 20 years. The Utah Center now includes 5 sites with 250 NICU beds and over 4,000 NICU admissions per year; representing nearly 90% of all Utah NICU care and almost 100% of all ELGAN/ELBW infants. Specific strengths of the Utah Center include 1) a population base unique from most other NRN Centers including a relatively high socioeconomic profile and a high proportion of non-Hispanic Caucasians; 2) established expertise in design, management, and analysis of multi-center randomized trials; 3) productive collaborative contributions to over 15 large randomized trials over the past decade; 4) past and current collaborative research studies within the University of Utah and Intermountain Healthcare consortium; 5) experienced research staff and support infrastructure including University of Utah Center for Clinical and Translational Science, Pediatric Pharmacology Program, and Institute of Women's and Child research; 6) productive research collaboration with Utah MFMU sites and faculty; 7) an enhanced Neonatal Follow-Up Program now integrated into the Department of Pediatrics; and 8) documented support from senior leadership across both the University of Utah Health Sciences and Intermountain Healthcare, including Medical Directors of the NICUs and MFMU sites at all participating hospitals. With the leadership of Dr. Yoder, 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 wide spread community, coupled with the highly successful Utah MFMU are major factors positioning the Utah Center for selection as a NRN study site.