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学术教师共同承诺在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力量来检验所述的假设，从而得出关于主要结局测量的有效结论。正在进行的多中心NICHD-NRN为临床试验设定了全国性的“黄金标准”，为了争取加入该组织，我们在加州大学洛杉矶分校的“虚拟NICHD-NRN型网站”中有必要的基础设施，称为新生儿临床研究中心（NCRC）， 2]选定的网站PI和备选PI具有开展和参与多中心试验的跟踪记录，这些记录来自一组高度协作的部门教师，3]IRB批准的综合新生儿数据库，[4] HRIF临床项目，保留率高达90%；[5]与发育儿科教师进行长达8岁的长期随访的能力；[6]在加州大学洛杉矶分校-新生儿重症监护病房培养参与临床试验的多学科辅助人员；[7]由新生儿科研究员、nnp、临床研究护士专家和新生儿科教师组成的患者招募的第一道防线，他们将确定符合条件的患者，并每周24/7天实施研究方案。8]经验丰富的临床研究护士协调员；9]定期的NCRC临床试验/数据分析会议，根据我们在该领域的现有研究优势，开发了“抗癫痫药物对低温下HIE新生儿神经保护的随机对照试验”这一概念应用。这使我们能够提出以下具体目标：1]根据合作协议与NRN一起参与正在进行的多中心项目，旨在对新生儿进行干预和观察性临床研究；2]为NRN指导委员会的想法和讨论做出贡献，旨在开发设计良好的临床试验，可在NRN站点实施；3]及时与中央数据协调中心和DSMC共享数据。并协助完成最后的结果报告，以及对可能从自然保护区产生的辅助项目进行发展和数据分析。加州大学洛杉矶分校作为一个潜在基地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.