NICHD Cooperative Multicenter Neonatal Research Network

描述（由申请人提供）：本申请是德克萨斯大学西南医学中心（UTSW）参加多中心临床项目，即尤尼斯肯尼迪施莱弗NICHD合作多中心新生儿研究网络（NRN）的再申请。自1986年NRN成立以来，悉尼大学一直是NRN的成员。Pablo S nchez医学博士、Luc Brion医学博士和Roy Heyne医学博士仍然分别担任首席研究员（PI）、候补PI和后续PI。作为NRN临床中心，悉尼大学拥有必要的学术、研究和临床基础设施，以确保NRN研究的持续卓越表现。新南威尔士大学新生儿围产期科已经表现出对临床研究的坚定承诺，在这项努力中，它得到了新南威尔士大学儿科部门及其临床设施的大力支持。帕克兰纪念医院（PMH）和儿童医疗中心（CMC）将进行与该RFA有关的临床研究。PMH拥有美国最大的新生儿分娩服务，而CMC新生儿重症监护室是一个新的，最先进的设施。新南威尔士大学和PMH的产科是母胎医学部门的一部分，确保临床研究的不同患者的持续来源。该患者群体主要是西班牙裔，这是一个服务不足但不断增加的人群，为了减少困扰该种族群体的健康差距，将其纳入临床试验至关重要。UTSW在NRN中有着良好的记录，其组织良好的临床研究系统证明了这一点，随机试验中符合条件的婴儿的比例很高，卓越的研究指导和完整的数据采集。研究婴儿的随访是在CMC的婴儿医疗家中整合的，随访率是NRN中最高的。PI在多中心随机临床试验方面有丰富的经验，例如提出的概念应用，包括长期给予维生素A和吸入一氧化氮，以预防支气管肺发育不良。通过在新生儿学和儿科传染病方面获得委员会认证，S nchez博士将为NRN提供有关新生儿传染病问题的专业知识，这是低出生体重婴儿中一个令人烦恼的问题。

DESCRIPTION (provided by applicant): This application is a reapplication from the University of Texas Southwestern Medical Center (UTSW) to participate in the multi-center clinical program, the Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (NRN). UTSW has been a member of the NRN since its inception in 1986. Pablo S nchez, MD, Luc Brion, MD, and Roy Heyne, MD remain as the Principal Investigator (PI), Alternate PI, and Follow-up PI, respectively. As an NRN clinical center, UTSW has the necessary academic, research and clinical infrastructure already in place that will assure continued excellence in the performance of NRN studies. The UTSW Neonatal-Perinatal division has demonstrated a strong commitment to clinical research, and in this endeavor, it has the strong support of the UTSW Pediatric Department as well as of its clinical facilities. Parkland Memorial Hospital (PMH) and Children's Medical Center (CMC) where the clinical studies pertaining to this RFA will be conducted. PMH boasts the largest inborn delivery service in the United States, while the CMC NICU is a new, state-of-the art facility. The Obstetric Dept. of UTSW and PMH is part of the Maternal Fetal Medicine Unit, 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 in order to reduce the health disparities that plague this ethnic group. UTSW has a proven track record within the NRN, as evidenced by its well organized clinical research system with a high percent- age 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 CMC, and the follow- up rates are among the highest in the NRN. The PI has extensive experience in the performance of multi- center, randomized clinical trials, such as the one proposed for the concept application consisting of prolonged administration of vitamin A and inhaled nitric oxide for prevention of bronchopulmonary dysplasia. By being board certified in both Neonatology and Pediatric Infectious Diseases, Dr. S nchez will provide expertise to the NRN on issues in neonatal infectious diseases, a vexing problem among low birth weight infants. PUBLIC HEALTH RELEVANCE (See instructions): The Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (NRN) is designed to perform interventional and observational clinical studies in newborns, particularly low birth weight infants. These studies, including that of the concept application on prolonged administration of vitamin A and inhaled nitric oxide for prevention of bronchopulmonary dysplasia, are designed to improve the health of high risk newborns and children