Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

尤尼斯·肯尼迪·施赖弗 (Eunice Kennedy Shriver) NICHD 合作多中心新生儿研究网络

基本信息

批准号：
10352224
负责人：
CHARLES Michael COTTEN
金额：
$ 27.88万
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 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10352224
关键词：
Active Sites Address Administrative Supplement Affect Antibiotics Autologous BDNF gene Biomedical Engineering Blood Cells Brain Injuries Bronchopulmonary Dysplasia Budgets Candida Candidiasis Cell Therapy Childhood Chromosome 8 Clinic Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Network Cohort Studies Communicable Diseases DNA Library Databases Dedications Delivery Rooms Development Early Diagnosis Enrollment Ensure Environment Faculty Fostering Funding Future Genes Genetic Variation Genetic study Goals Gold Health Health system Healthcare Infant Infant Care Inositol Institution Institutional Review Boards Interdisciplinary Study Intervention Investigation Lead Link Low Birth Weight Infant Medical Medical center Mentors Methodology Molecular Morbidity - disease rate Multicenter Neonatal Research Network National Institute of Child Health and Human Development Necrotizing Enterocolitis Neonatal Neonatal Intensive Care Neonatology Neurodevelopmental Impairment Newborn Infant North Carolina Obstetric Delivery Outcome Paper Patent Ductus Arteriosus Pathway interactions Patients Perinatal Phosphorylases Pregnancy Premature Infant Protocols documentation Psychologist Publications Publishing Recording of previous events Reporting Research Research Institute Research Personnel Resources Retinal Diseases Retinopathy of Prematurity Risk Role Sampling Scientist Site The science of Mycology Time Transfusion Umbilical Cord Blood United States National Institutes of Health Universities Validation Variant Vulnerable Populations career career development clinical center clinical research site cohort data repository disability experience extreme prematurity follow-up genetic association genetic epidemiology genetic variant genome-wide improved improved outcome infant outcome innovation interdisciplinary approach intraventricular hemorrhage late onset sepsis medical schools mortality risk multidisciplinary neonatal encephalopathy neonatal health novel patient population pediatric department phase 3 study phase III trial premature prospective public health relevance risk variant skills study population tool working group

项目摘要

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.

描述（由申请人提供）：杜克大学医学院，新生儿学部热情地提交了Eunnece Kennedy Shriver NICHD赞助的合作Multicel Multicel Neonatarch网络（NRN）的第四个周期。在Newbern婴儿D医学和神经发育结果中。 NRN; 3）介绍NRN的态度，以确保启用这些AIMS的Inneonation Inneonatal Inneonation Inneonate Innegore Ongore Ongore。 Chapel Hill（UNC）的北卡罗莱纳州加入了杜克大学。招募IIIIII III III III II II II II II II III II III II III III III III II III II II IIII章，并在杜克大学（UNC）和WAKEM的多个学科随访诊所中输血和输血主要的网络项目，“新生儿念珠菌病的早期诊断”和“ Anonyzed DNA库”，结合了杜克大学传染病，医学真菌学，生物医学工程S.念珠菌试验材料的融合，继续进行分析和造成的贡献。 Candisisis的降低是磷酸化途径基因中的变体与PAS NRN研究者的BPD风险年份之间的变体之间的降低。作为ASED ASED ASED ASED ASED ASED ASED ASTH资助的ASED，对与早产的遗传相关性的调查是Habe所产生的。 NRN的初级教职员工。 Patentus US的策略（PDA试验）已由NRN进行了审查，并可能在2016 - 2021年的周期中开始。）2015年1月，被批准发展为临床试验，将继续进行临床试验，并为临床试验带来临床试验。改善了我们的树研究机构和整个州的护理人员。