NICHD Cooperative Multicenter Neonatal Research Network

 描述（由申请人提供）：加州大学洛杉矶分校新生儿科的学术教师强烈致力于在NRN多中心试验主持下的所有临床研究活动。加州大学洛杉矶分校的“虚拟研究中心”和“团队科学”在进行我们的集体临床试验方面是独一无二的;在五个NICU整合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，以及与校园内的临床和基础科学研究人员的互动。其他优势包括：选定的研究中心PI和替代PI在一组高度合作的部门教师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，HRIF诊所计划，保留率> 95%，长期随访-年龄不超过8岁，拥有发育儿科系，并在UCLA附属NICU建立了临床试验参与文化。我们在患者招募中的第一步也是至关重要的一步是，NRN研究中心PI、研究协调员和护士与不同的NICU团队成员（即儿科医生、主管和护士、研究员和NNPs）之间每天保持全天候的密切沟通，这些团队成员负责识别合格患者并实施研究方案，以加强招募和保留，并最大限度地减少方案违反。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对新生儿结局的临床相关性。2]根据合作协议，在一项旨在对婴儿进行干预性和观察性纵向研究的正在进行的项目中，成功竞争保留NICHD的会员资格。3]及时与数据协调中心和数据与安全性监查委员会共享数据，并沿着可能来自NRN的所有辅助项目的开发和数据分析，为结果的最终报告做出贡献。4]为NRN指导委员会未来的想法和讨论提供有价值的贡献，这些想法和讨论将发展为设计良好的假设驱动的临床试验，这些临床试验可以在NRN研究中心实施。

 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.