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: 8081377
• 负责人: UDAY P DEVASKAR
• 金额: $ 30.8万
• 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/8081377
• 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师集体承诺在NRN多中心试验的主持下进行临床研究。我们将招募足够数量的患者，以产生必要的把握度来检验所述假设，从而得出关于主要结局指标的有效结论。为了竞争正在进行的多中心NICHD-NRN的成员资格，该NICHD-NRN为临床试验设定了全国范围的“黄金标准”，我们有1]在我们的UCLA“虚拟NICHD-NRN类型站点”称为新生儿临床研究中心（NCRC）的必要基础设施，2]从一组高度协作的部门教师中选择具有进行和参与多中心试验的跟踪记录的站点PI和备用PI，3] IRB批准的综合新生儿数据库，4] HRIF临床项目留存率>90%，5]发育儿科教师能够长期随访至8岁，6] UCLA-NICU中参与临床试验的多学科辅助人员的培养，7]患者招募的第一道防线，包括新生儿研究员、NNP，临床研究护士专家和新生儿学院，他们将识别合格的患者并每周7天/24小时实施研究方案，和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，导致概念应用的开发，“基于我们在该领域现有的研究优势，在低温下对HIE新生儿进行抗癫痫药物神经保护的随机对照试验。这使我们能够提出以下具体目标：1）根据合作协议与NRN一起参与一项正在进行的多中心项目，该项目旨在对新生儿进行干预性和观察性临床研究，2）为NRN指导委员会的想法和讨论做出贡献，旨在开发设计良好的临床试验，这些临床试验可在NRN研究中心实施，3）及时与集中数据协调中心和DSMC共享数据，并为最终报告结果做出贡献，沿着NRN可能出现的辅助项目的开发和数据分析。UCLA作为潜在研究中心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证明是对NRN的重要贡献。