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）再次申请参加多中心临床项目，Eunice Kennedy Shriver NICHD合作多中心新生儿研究网络（NRN）。UTSW自1986年成立以来一直是NRN的成员。巴勃罗S nchez，MD、Luc Brion，MD和Roy Heyne，MD分别担任主要研究者（PI）、替代PI和随访PI。作为NRN临床中心，UTSW拥有必要的学术，研究和临床基础设施，这将确保NRN研究的持续卓越表现。UTSW新生儿-围产期部门已经证明了对临床研究的坚定承诺，在这奋进，它得到了UTSW儿科部门及其临床设施的大力支持。帕克兰纪念医院（PMH）和儿童医学中心（CMC），将在此开展与RFA相关的临床研究。PMH拥有美国最大的先天性分娩服务，而CMC NICU是一个新的，最先进的设施。产科UTSW和PMH的中心是母胎医学部门的一部分，确保了临床研究的多样化患者的持续来源。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，为了减少困扰这一种族群体的健康差异，将其纳入临床试验至关重要。UTSW在NRN中拥有良好的记录，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，卓越的研究进行和完整的数据采集。研究婴儿的随访是在CMC的婴儿医疗之家进行的，随访率在NRN中是最高的。PI在开展多中心、随机临床试验方面具有丰富的经验，例如，拟定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。通过获得新生儿和儿科传染病委员会认证，S nchez博士将为NRN提供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。 公共卫生相关性（见说明）：Eunice Kennedy Shriver NICHD合作多中心新生儿研究网络（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。这些研究，包括长期服用维生素A和吸入一氧化氮预防支气管肺发育不良的概念应用研究，旨在改善高危新生儿和儿童的健康

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