NICHD Cooperative Multicenter Neonatal Research Network

NICHD 多中心新生儿合作研究网络

• 批准号: 9079306
• 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 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9079306
• 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; Enrollment; Environment; Faculty; Fostering; Future; Goals; Gold; Health Sciences; Hospitals; Infant; Institutes; Intervention; Investigation; Longitudinal Studies; 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; Reporting; Research; Research Activity; Research Design; Research Infrastructure; Research Institute; Research Personnel; Safety; Sampling; Science; Scientist; Site; Testing; Translating; Translational Research; U-Series Cooperative Agreements; Work; clinical practice; clinically relevant; data sharing; design; empowered; ethnic diversity; evidence base; follow-up; high risk infant; innovation; journal article; meetings; 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学术人员致力于在 NRN 多中心试验的支持下继续开展所有临床研究活动。 UCLA的“虚拟研究中心”和“团队科学”在承担我们的集体临床试验方面是独一无二的；整合五个新生儿重症监护室的 HRIF 卫星诊所；对临床研究的集体奉献，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：选定的中心 PI 和候补 PI 拥有在一组高度协作的部门教职人员中进行和参与多中心试验的记录、IR 批准的综合新生儿和围产期数据库、保留率 >95% 的 HRIF 临床项目以及发育儿科教职人员对 8 岁儿童的长期随访，以及 UCLA 附属机构的临床试验参与文化 新生儿重症监护室。我们在患者招募方面的第一步也是至关重要的一步是每天在 NRN 站点 PI、研究协调员之间保持全天候密切沟通，并交接给不同的 NICU 团队成员（即新生儿科医生、主管和护士、研究员和 NNP），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最大限度地减少违反方案的情况。我们定期举办 NCRC 临床试验/数据分析会议。因此，我们提出以下目标： 1] 在 NRN 内制定科学合理的辅助研究方案，这些方案将在大多数参与中心进行严格测试和实施，以便能够确定干预措施与新生儿结局的临床相关性。 2] 根据一项旨在对婴儿进行介入和观察性纵向研究的正在进行的计划的合作协议，成功竞争保留 NICHD 的会员资格。 3] 及时与数据协调中心以及数据和安全监测委员会共享数据，并为结果的最终报告以及 NRN 可能出现的所有辅助项目的开发和数据分析做出贡献。 4] 为 NRN 指导委员会的未来想法和讨论提供有价值的贡献，这些想法和讨论将发展成为可在 NRN 站点实施的精心设计的假设驱动的临床试验。