NICHD Cooperative Multicenter Neonatal Research Network

描述（由申请人提供）： 该提案是德克萨斯大学（UT）位于达拉斯的西南医学中心根据合作协议（RFA：HD-04-010）与NICHD共同参与正在进行的多中心 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。UT西南网站自1986年成立以来一直是NRN的成员。巴勃罗J. Sanchez，MD将担任主要研究者（PI），而替代和随访PI仍为Walid A。Salhab医学博士罗伊·J·海恩医学博士 作为NRN的临床中心，UT Southwestern拥有必要的学术，研究和临床基础设施，这将确保NRN临床研究的持续卓越表现。UT Southwestern的新生儿-围产期部门对临床研究表现出了坚定的承诺，在这一奋进中，它得到了UT Southwestern儿科及其临床设施、帕克兰纪念医院（PMH）的大力支持。和儿童医疗中心。PMH是UT西南部的教学机构，将进行与该RFA相关的临床研究。它拥有美国最大的先天分娩服务，每年有超过15，000例分娩。UT西南和PMH的产科部门是产妇胎儿医学单位的一部分，其产科服务高度整合在达拉斯的目标社区的医疗保健提供服务，确保临床研究的不同患者的持续来源。该患者人群主要是西班牙裔，这是一个服务不足但不断增加的人群，其纳入临床研究 为了减少困扰这一族裔群体的健康差距，试验是必不可少的，也是必要的。此外，UT Southwestern在NRN内有着良好的记录，其组织良好的临床研究系统证明了这一点，高比例的合格婴儿参加了随机试验，卓越的研究和完整的数据采集。对研究婴儿的随访是在儿童医疗中心的婴儿医疗之家进行的，这些婴儿的随访率超过90%，是NRN中最高的。最后，本提案的PI在多中心、随机临床试验的实施和开展方面具有丰富的经验。凭借在新生儿和儿科传染病委员会认证，桑切斯博士将提供专业知识，NRN在新生儿问题。 传染病是低出生体重婴儿的一个棘手问题。这将导致关键研究的设计，如迟发性感染管理的概念提案，最终可能会减少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.