NICHD Cooperative Multicenter Neonatal Research Network - UCLA

描述(由申请人提供)：加州大学洛杉矶分校新生儿科的教职员工集体承诺在NRN多中心试验的支持下进行临床研究。我们将招募足够数量的患者来产生必要的能量来检验所述的假设，从而获得关于主要结果衡量标准的有效结论。为了争夺正在进行的多中心NICHD-NRN的成员资格，它为临床试验设定了全国的“黄金标准”，我们在加州大学洛杉矶分校的“虚拟NICHD-NRN类型站点”中有1)必要的基础设施，称为新生儿临床研究中心(NCRC)，2]选定的站点PI和备用PI具有从一组高度协作的分区教员进行和参与多中心试验的记录，3]IRB批准的全面新生儿数据库，4]HRIF临床计划与&GT；90%的保留率，5)对8岁以下发展中的儿科教师进行长期跟踪的能力，6)在加州大学洛杉矶分校NICU中参与临床试验的多学科辅助人员的培养，7]招募患者的第一道防线，由新生儿研究员、NNPs、临床研究护士专家和新生儿学院组成，他们将识别符合条件的患者并执行研究方案，8)经验丰富的临床研究协调员，9]定期NCRC临床试验/数据分析会议，导致概念应用的开发，根据我们在这一领域的现有研究实力，对体温过低的HIE新生儿使用抗癫痫药物进行神经保护的随机对照试验。这授权我们提出以下具体目标：1)根据合作协议与NRN一起参与正在进行的多中心计划，该计划旨在对新生儿进行干预性和观察性临床研究；2)为NRN指导委员会提供意见和讨论，旨在开发可在NRN站点实施的精心设计的临床试验；3)与中央数据协调中心和DSMC及时共享数据，并为NRN可能出现的辅助项目的最终结果报告以及开发和数据分析做出贡献。加州大学洛杉矶分校作为一个潜在的地点的参与将为我们提供一个令人兴奋的机会，我们预计从洛杉矶地区招募不同种族的患者将被证明是对NRN的重要贡献。

DESCRIPTION (provided by applicant): Academic faculty members of the division of Neonatology at UCLA have collectively made a commitment to conduct clinical research under the auspices of the NRN multi-center trials. We will recruit adequate number of patients to generate necessary power to test stated hypotheses, thereby allowing valid conclusions about primary outcome measures. To compete for membership in the ongoing multi-center NICHD-NRN that sets the nation-wide "gold standard" for clinical trials, we have 1] the necessary infrastructure in our UCLA "Virtual NICHD-NRN type site" called the Neonatal Clinical Research Center (NCRC), 2] selected site PI and alternate PI with track records in conducting and participating in multi-center trials from a group of highly collaborative divisional faculty, 3] IRB approved comprehensive Neonatal Database, 4] HRIF clinic Program with >90% retention rate, 5] capability of long term follow-up with Developmental Pediatric faculty up to 8 years of age, 6] culture in UCLA-NICUs among multi-disciplinary ancillary staff of participating in clinical trials, 7] First line of defense for patient recruitment consisting of Neonatology fellows, NNPs, Clinical Research Nurse Specialists, and Neonatology Faculty who will identify eligible patients and implement study protocols 24/7 days a week, and 8] Experienced clinical research nurse coordinator, 9] Regular NCRC clinical trials/data analysis sessions that led to development of a concept application, "Randomized Control Trial of Neuro-protection by Anti-Seizure Medications in HIE Neonates subjected to Hypothermia based on our existent research strengths in this field. This empowers us to propose the following specific aims:1] To participate with NRN under a cooperative agreement in an ongoing multi-center program designed to perform interventional and observational clinical studies in newborn babies, 2] To contribute to the steering committee of NRN ideas and discussions targeted at developing well designed clinical trials that can be implemented in NRN sites, and 3] To share data in a timely manner with the Centralized Data Coordinating Center and the DSMC, and contribute towards the final reporting of results along with development and data analyses of ancillary projects that may emerge from the NRN. UCLA's participation as a potential site will provide an exciting opportunity for us and we project that recruitment of patients with diverse ethnicity from the Los Angeles area will prove to be an important contribution to the NRN.