Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

 描述（由申请人提供）：杜克大学医学院新生儿科部热情地提交了连续第四个周期参加Eunice Kennedy Shriver NICHD赞助的合作多中心新生儿研究网络（NRN）的更新申请。NRN的目的是在新生儿中进行干预性和观察性临床研究，特别是低出生体重或妊娠期的新生儿，从而改善医疗和神经发育结果。杜克大学支持NRN的目标是：1）优先考虑并执行经批准的NRN方案，同时保持> 90%的随访率; 2）带来创新的、合作的多学科研究机会 3）向年轻教师介绍NRN辅导机会，以培养新的想法，并确保新生儿重症监护的持续进展。 为了支持这些目标，杜克增加了两个卫星站点。2009年1月，当北卡罗来纳大学教堂山分校（University of North Carolina at查佩尔山，简称教堂山）加入杜克时，杜克成为第一个加入独立学术机构的网络网站。WakeMed医疗中心于2014年7月加入。增加了Risk和WakeMed，扩大了研究人群，增强了研究中心的临床试验专业知识。它还增加了NRN研究对我们地区和国家新生儿保健的影响。杜克研究中心（杜克，韦科医学中心）在NRN肌醇III期试验中的入组率最高，是网络通用数据库和早产儿输血研究中入组率最高的研究中心之一。杜克、杜克大学和WakeMed维持多学科随访诊所，这些诊所维持临床试验和队列研究的随访率> 90%。杜克领导了两个主要的网络项目，“新生儿疟原虫病的早期诊断”和“扩增的DNA库”，这两个项目结合了杜克在传染病、医学真菌学、生物医学工程、遗传流行病学和分子方法学方面的专业知识。念珠菌试验材料继续进行分析，并提供了可能有助于减少念珠菌病的信息。DNA库样本和相关的临床数据已被用于确定磷酸化酶途径基因变异与BPD风险之间的关联，以及BDNF基因变异与严重视网膜病变之间的关联。今年在PAS NRN，研究人员报告了8号染色体基因内区域的变异与严重NEC之间的关联，达到了全基因组意义。该银行的数据也被用作其他NIH资助的遗传与早产发病率相关研究的验证队列。除了这两项研究产生的资源仍在使用的调查人员从多个网站，杜克已参与初级教师和学员在NRN。八位不同的杜克研究中心研究者共同撰写了上一周期发表的38篇NRN论文（8篇第一作者论文）。 杜克、杜克大学和WakeMed将继续努力，最大限度地增加招募人数，并保持队列研究和临床试验的随访率> 90%。NRN已经审查了脑损伤细胞疗法和动脉未闭管理策略（PDA试验）的创新研究，并可能在2016 - 2021周期开始。PDA方案由Laughton博士（Dr. Laughton）领导。新生儿脑病（Cotten）婴儿的自体脐带血研究于2015年1月作为NRN概念提出，并被批准发展为NRN考虑的完整方案。杜克研究中心将继续这些努力，并为临床试验带来更多新概念。杜克，杜克大学和WakeMed儿科部门以及卫生系统完全支持我们对NRN的持续合作承诺，因为我们坚信，我们与NRN的互动直接影响并改善了我们三个机构和整个州的婴儿护理。

 DESCRIPTION (provided by applicant): The Duke University School of Medicine, Division of Neonatology enthusiastically submits this renewal application for a fourth consecutive cycle of participation in the Eunice Kennedy Shriver NICHD-sponsored Cooperative Multicenter Neonatal Research Network (NRN). The NRN's purpose is to perform interventional and observational clinical studies in newborn infants, particularly those of low birth weight or gestation, that lead to improved medical and neurodevelopmental outcomes. Duke's aims in support of the NRN are to: 1) prioritize and conduct approved NRN protocols while maintaining a > 90% follow-up rate; 2) bring innovative, collaborative multidisciplinary research opportunities to the NRN; 3) introduce young faculty to NRN mentoring opportunities to foster new ideas and ensure ongoing progress in Neonatal Intensive Care. In support of these aims Duke added two satellite sites. In January 2009, Duke was the first Network site to add an independent academic institution when the University of North Carolina at Chapel Hill (UNC) joined Duke. WakeMed Medical Center was added in July 2014. The addition of UNC and WakeMed expands the study population and enhances the Site's clinical trial expertise. It also increases the impact of NRN studies on neonatal health care in our region and State. The Duke Site (Duke, UNC, WakeMed) leads enrollment in the NRN Inositol phase III trial and is among the highest enrolling sites in th Network's Generic Database and Transfusion for Prematures studies. Duke, UNC, and WakeMed maintain multidisciplinary follow-up clinics which maintain follow-up rates for clinical trials and cohort studies > 90%. Duke leads two major Network projects, "Early Diagnosis of Neonatal Candidiasis" and the "Anonymized DNA Bank", that combined Duke' expertise in Infectious Diseases, Medical Mycology, Biomedical Engineering, Genetic Epidemiology and Molecular Methodologies. Candida trial materials continue to be analyzed and have provided information that has likely contributed to the decrease in Candidiasis. The DNA bank samples and linked clinical data have been used to identify associations between variants in phosphorylase pathway genes and BPD risk, and variants in the BDNF gene and severe retinopathy. This year at PAS NRN investigators reported associations between variants in an intragenic region on chromosome 8 and severe NEC that reached genome wide significance. The Bank's data has also been used as a validation cohort for other NIH-funded investigations of genetic associations with morbidities of prematurity. In addition to these two studies which have produced resources still being used by investigators from multiple sites, Duke has made involvement of junior faculty and trainees in the NRN. Eight different Duke Site investigators have co-authored 38 NRN papers published in the last cycle (8 first-author papers). Duke, UNC, and WakeMed will continue efforts to maximize enrollment and maintain follow-up for cohort studies and clinical trials > 90%. Innovative studies of cell therapy for brain injury and management strategies for Patent Ductus Arteriosus (PDA trial) have been reviewed by the NRN and are likely to begin in the 2016 - 2021 cycle. The PDA protocol is led by Dr. Laughton (UNC). The autologous cord blood study for infants with neonatal encephalopathy (Cotten) was presented as an NRN concept in January 2015, and approved to be developed into a full protocol for NRN consideration. The Duke Site will continue these efforts plus bring additional novel concepts for clinical trials. The Duke, UNC, and WakeMed Departments of Pediatrics, and the Health Systems fully support our ongoing collaborative commitment to the NRN, as we firmly believe that our interactions with the NRN have directly affected and improved the care of infants in our three institutions and throughout our State.