NICHD Cooperative Multicenter Neonatal Research Network - UCLA

NICHD 合作多中心新生儿研究网络 - 加州大学洛杉矶分校

• 批准号: 8643284
• 负责人: UDAY P DEVASKAR
• 金额: $ 29.49万
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8643284
• 关键词: 6 year old; 8 year old; Admission activity; Ancillary Study; Area; Auditory; California; Childhood; Clinic; Clinical; Clinical Nurse Specialists; Clinical Nursing Research; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Commit; Data; Data Analyses; Data Coordinating Center; Databases; Development; Discipline of obstetrics; Doctor of Medicine; Doctor of Philosophy; Ethnic Origin; Faculty; Flavoring; Funding; Gold; Housing; Infant Development; Institutional Review Boards; Leadership; Los Angeles; Medical; Monitor; Multi-Institutional Clinical Trial; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Intensive Care Units; Neonatal Nursing; Neonatology; Neurology; Newborn Infant; Nurse Practitioners; Nurses; Occupational; Operative Surgical Procedures; Ophthalmology; Outcome Measure; Patient Recruitments; Patients; Perinatal; Pharmaceutical Preparations; Protocols documentation; Pulmonology; Quality of Care; Randomized Controlled Trials; Records; Recruitment Activity; Reporting; Research; Research Design; Research Infrastructure; Safety; Sample Size; Seizures; Services; Site; Social Work; Specialist; Structure; Supervision; Testing; Time; Translating; U-Series Cooperative Agreements; Universities; Vermont; Work; base; clinical care; clinical practice; data sharing; design; empowered; experience; feeding; follow-up; high risk infant; journal article; member; natural hypothermia; neonate; neurodevelopment; primary outcome; programs; virtual

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.

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员集体承诺在 NRN 多中心试验的支持下开展临床研究。我们将招募足够数量的患者，以产生必要的力量来测试既定的假设，从而得出关于主要结果指标的有效结论。为了争夺正在进行的多中心 NICHD-NRN 的成员资格，该机构为全国范围内的临床试验设定了“黄金标准”，我们 1] 在我们的 UCLA“虚拟 NICHD-NRN 型站点”（称为新生儿临床研究中心 (NCRC)）中拥有必要的基础设施，2] 选择站点 PI 和备用 PI，这些 PI 具有由一组高度协作的组织进行和参与多中心试验的记录。 3] IRB 批准了综合性新生儿数据库，4] HRIF 诊所项目保留率 >90%，5] 发育儿科教职人员进行长期随访直至 8 岁的能力，6] 参与临床试验的多学科辅助人员在 UCLA-NICU 中的文化，7] 由新生儿科研究员组成的患者招募的第一道防线， NNP、临床研究护士专家和新生儿科教师将每周 24/7 天识别符合条件的患者并实施研究方案，以及 8] 经验丰富的临床研究护士协调员，9] 定期 NCRC 临床试验/数据分析会议，从而开发了概念应用程序，“根据我们现有的研究，在遭受低温的 HIE 新生儿中使用抗癫痫药物进行神经保护的随机对照试验” 该领域的优势。这使我们能够提出以下具体目标：1] 根据合作协议与 NRN 参与一项正在进行的多中心计划，该计划旨在对新生儿进行介入和观察性临床研究，2] 为 NRN 指导委员会做出贡献，旨在开发设计良好、可在 NRN 站点实施的临床试验，并进行讨论，以及 3] 及时与 NRN 分享数据 集中数据协调中心和 DSMC，并为 NRN 可能出现的辅助项目的开发和数据分析以及结果的最终报告做出贡献。加州大学洛杉矶分校作为潜在站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。