NICHD Cooperative Multicenter Neonatal Research Network

描述(由申请人提供)：此建议书是德克萨斯大学(UT)达拉斯西南医学中心根据正在进行的多中心合作协议(RFA：HD-04-010)再次申请与NICHD合作 临床计划，合作多中心新生儿研究网络(NRN)。NRN旨在对新生儿，特别是低出生体重儿进行干预性和观察性临床研究。德克萨斯大学西南部站点自1986年成立以来一直是NRN的成员。医学博士巴勃罗·J·桑切斯将担任首席研究员(PI)，而替代和后续的首席研究员仍然是医学博士Walid A.Salhab和医学博士Roy J.Heyne。作为NRN的临床中心，德克萨斯大学西南分校拥有必要的学术、研究和临床基础设施，将确保NRN临床研究的持续卓越表现。德克萨斯大学西南分校的新生儿-围产期部门表现出对临床研究的坚定承诺，在这一努力中，它得到了德克萨斯大学西南分校儿科及其临床设施、帕克兰纪念医院(PMH)和儿童医学中心的大力支持。PMH是德克萨斯大学西南分校的教学设施，将在那里进行与RFA有关的临床研究。它号称拥有美国最大的先天递送服务，每年有超过15,000次递送。德克萨斯大学西南分校和玛嘉烈医院的产科是母胎医学部的一部分，其产科服务与达拉斯目标社区的医疗保健服务高度整合，确保了继续为临床研究提供多样化的患者来源。这些患者主要是西班牙裔，这是一个服务不足但不断增加的人口，他们的临床 为了减少困扰这一族裔群体的健康差距，试验是必要和可取的。此外，德克萨斯大学西南分校在NRN中拥有经过验证的跟踪记录，其组织良好的临床研究系统证明了这一点，该系统在随机试验中登记了高比例的合格婴儿，出色地进行了研究，并完成了数据收集。对研究婴儿的随访被整合到儿童医学中心的婴儿医疗之家，这些婴儿的随访率超过90%，是NRN中最高的之一。最后，这项建议的PI在多中心随机临床试验的执行和实施方面拥有丰富的经验。凭借在新生儿学和儿科传染病方面的董事会认证，桑切斯博士将为NRN提供有关新生儿问题的专业知识 传染病，这是低出生体重儿的一个令人烦恼的问题。这将导致关键研究的设计，例如关于迟发性感染管理的概念建议，最终可能减轻感染对这些高危婴儿长期神经发育障碍的影响。

DESCRIPTION (provided by applicant): This proposal is a reapplication from the University of Texas (UT) Southwestern Medical Center at Dallas to participate with the NICHD under a cooperative agreement (RFA: HD-04-010) in an ongoing multicenter clinical program, the Cooperative Multicenter Neonatal Research Network (NRN). The NRN is designed to perform interventional and observational clinical studies in newborns, particularly low birth weight infants. The UT Southwestern site has been a member of the NRN since its inception in 1986. Pablo J. Sanchez, MD will serve as the Principal Investigator (PI), while the Alternate and Follow-up PIs remain Walid A. Salhab, M.D. and Roy J. Heyne, M.D. As a clinical center of the NRN, UT Southwestern has the necessary academic, research and clinical infrastructure already in place that will assure continued excellence in the performance of the clinical studies of the NRN. The Neonatal-Perinatal division of UT Southwestern has demonstrated a strong commitment to clinical research, and in this endeavor, it has the strong support of the Pediatric Department at UT Southwestern as well as of its clinical facilities, Parkland Memorial Hospital (PMH) and Children's Medical Center. PMH is the teaching facility of UT Southwestern where the clinical studies pertaining to this RFA will be performed. It boasts the largest inborn delivery service in the United States, with over 15,000 deliveries every year. The Obstetric Department of UT Southwestern and PMH is part of the Maternal Fetal Medicine Unit, and its obstetric service is highly integrated within the health care delivery services of targeted communities of Dallas, assuring a continued source of diverse patients for clinical studies. This patient population is predominantly Hispanic, an underserved but increasing population whose inclusion in clinical trials is essential and desired in order to reduce the health disparities that plague this ethnic group. In addition, UT Southwestern has a proven track record within the NRN, as evidenced by its well organized clinical research system with a high percentage of eligible infants enrolled in randomized trials, excellence in conducting the studies, and complete data acquisition. Follow-up of study infants is integrated within the infant's medical home at Children's Medical Center, and the follow-up rates for these infants exceed 90 percent, among the highest in the NRN. Finally, the PI of this proposal has extensive experience in the performance and conduct of multi-center, randomized clinical trials. By virtue of being board certified in both Neonatology and Pediatric Infectious Diseases, Dr. Sanchez will provide expertise to the NRN on issues in neonatal infectious diseases, a vexing problem among low birth weight infants. This will lead to the design of key studies such as the concept proposal on management of late-onset infections that ultimately may lessen the impact of infection on long-term neurodevelopmental disabilities among these high-risk infants.