NICHD Cooperative Multicenter Neonatal Research Network

NICHD 多中心新生儿合作研究网络

• 批准号: 9257434
• 负责人: UDAY P DEVASKAR
• 金额: $ 0.77万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9257434
• 关键词: 8 year old; Admission activity; Ancillary Study; Antelopes; Area; Basic Science; Birth; Charge; Child; Childhood; Clinic; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Communication; Data; Data Analyses; Data Coordinating Center; Databases; Dedications; Development; Doctor of Medicine; Doctor of Philosophy; Eligibility Determination; Enrollment; Environment; Faculty; Fostering; Future; Goals; Gold; Health Sciences; Hospitals; Infant; Institutes; Intervention; Investigation; Longitudinal observational study; Low Birth Weight Infant; Medical; Medicine; Mission; Monitor; Multi-Institutional Clinical Trial; Multicenter Neonatal Research Network; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Neonatology; Nursing Staff; Observational Study; Patient Recruitments; Patients; Perinatal; Population; Population Heterogeneity; Protocols documentation; Records; Recruitment Activity; Reporting; Research; Research Activity; Research Design; Research Infrastructure; Research Institute; Research Personnel; Safety; Sampling; Science; Scientist; Site; Testing; Time; Translating; Translational Research; U-Series Cooperative Agreements; Work; clinical practice; clinically relevant; cohesion; data sharing; design; empowered; ethnic diversity; evidence base; follow-up; high risk infant; innovation; journal article; member; neonatal outcome; patient population; premature; programs; protocol violation; public health relevance; retention rate; sound; virtual

 DESCRIPTION (provided by applicant): Academic faculty in the UCLA Neonatology Division are strongly devoted to remaining in all clinical research activities under the auspices of the NRN multi-center trials. UCLA's "virtual research center" and "team science" is unique in undertaking our collective clinical trial; integrating HRIF satellite clinics at five NICUs; a collective dedication to clinical research, ability to translate discoveries into clinical trials, nd interaction with clinical and basic science investigators on campus. Additional strengths include the following: selected site PIs and alternate PI have track records in conducting and participating in multi- center trials within a group of highly collaborative divisional faculty, IR approved comprehensive Neonatal and Perinatal Databases, HRIF clinic programs with >95 % retention rates and long term follow-up to 8 years of age with Developmental Pediatric faculty and an established culture of clinical trial participation in UCLA affiliated NICUs. Our first and vital step in patient recruitment is maintaining around the clock close communication daily between the NRN site PIs, research coordinators, and handoffs to varying NICU team members (i.e. neonatologist, charge and staff nurses, fellows, and NNPs) who identify eligible patients and implement study protocols to strengthen recruitment and retention and minimize protocol violations. We hold regular NCRC clinical trials/data analysis sessions. Therefore we propose the following aims: 1] To develop scientifically sound protocols within the NRN for ancillary studies that will be rigorously tested and implemented at most participating centers to be able to identify the clinical relevance of the intervention to neonatal outcomes. 2] To successfully compete to retain membership with the NICHD under a cooperative agreement in an ongoing program designed to perform interventional and observational longitudinal studies in infants. 3] To share data in a timely manner with the Data Coordinating Center and Data and Safety Monitoring Committee and contribute towards the final reporting of results along with development and data analysis of all ancillary projects that may emerge from the NRN. 4] To provide valuable contributions for future ideas and discussions in the NRN steering committee that will develop into well designed hypotheses driven clinical trials that can be implemented across NRN sites.

 描述(由申请人提供)：加州大学洛杉矶分校新生儿科的教师致力于在NRN多中心试验支持下的所有临床研究活动中留下来。加州大学洛杉矶分校的“虚拟研究中心”和“团队科学”在以下方面独树一帜：进行集体临床试验；整合五个NICU的HRIF卫星诊所；集体致力于临床研究；将发现转化为临床试验的能力；以及与校园内临床和基础科学研究人员的互动。其他优势包括：选定的现场PI和备用PI在一组高度协作的分区教员中进行和参与多中心试验的记录，IR批准的全面的新生儿和围产期数据库，HRIF临床项目&gt；95%的保留率和对8岁的长期跟踪与发展性儿科教员，以及在加州大学洛杉矶分校附属NICU参与临床试验的既定文化。我们招募患者的第一步也是至关重要的一步是保持NRN现场PI、研究协调员之间每天24小时的密切沟通，并将其移交给不同的NICU团队成员(即新生儿专家、主管和专职护士、研究员和NNPs)，他们识别符合条件的患者并实施研究方案，以加强招募和保留，并将违反礼仪的行为降至最低。我们定期举行NCRC临床试验/数据分析会议。因此，我们提出以下目标：1]在NRN内为辅助研究制定科学合理的方案，这些方案将在大多数参与中心进行严格的测试和实施，以便能够确定干预措施与新生儿结局的临床相关性。2]在一项旨在对婴儿进行干预性和观察性纵向研究的持续计划中，根据一项合作协议，成功地竞争保留NICHD的成员资格。3]及时与数据协调中心和数据与安全监测委员会共享数据，并协助最后报告结果，以及编制和分析国家核动力网可能产生的所有辅助项目。4]为NRN指导委员会未来的想法和讨论提供有价值的贡献，这些委员会将发展成设计良好的假设驱动的临床试验，可以在NRN地点实施。