MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

母胎医学单位的多中心网络

• 批准号: 2392492
• 负责人: MICHAEL W. VARNER
• 金额: $ 59.65万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-05-01 至 2001-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2392492
• 关键词: chemoprevention; clinical research; cooperative study; corticosteroid analog; corticosteroids; dexamethasone; drug screening /evaluation; embryo /fetus chemotherapy; female; gene therapy; genetic counseling; gestational diabetes mellitus; hormone therapy; human pregnant subject; human subject; human therapy evaluation; low birth weight infant human; mother /infant health care; obstetrics; perinatal; preeclampsia; pregnancy; pregnancy immunology; premature labor; prenatal care; prenatal diagnosis

The purpose of this proposal is to show that the Division of Maternal- Fetal Medicine (MFM) at the University of Utah Health Sciences Center is an excellent candidate to become a member of the Maternal-Fetal Medicine Units (MFMU) Network sponsored by the National Institute of Child Health and Human Development. The MFM Division has the past record of academic productivity, previous success in participating in multicenter trials, access to a suitable and cooperative patient population, and several unique strengths which allows the MFM Division to bring to the MFMU Network the ability to successfully perform clinical trials with a strong basic science background. The specific aims of this proposal are: (1) to describe the organizational structure of the division with regard to the MFMU network, the demographics of our patient population, and the strengths of individual division members; (2) to show our ability to design and propose a multicenter trial; and (3) to describe special strengths of the division which will be made available to the MFMU network. We have been successful in several multicenter trials over the past five years, and our participation in these studies will be detailed. We will describe the organization of our research efforts, the patient population available for study, research nurse staffing, the clinical strengths of our program, our computerized perinatal data base, and the neonatology services available for multicenter studies. Our proposed study, entitled "The safety and efficacy of single vs. weekly administration of corticosteroids for the acceleration of fetal lung maturity", will demonstrate our ability to use our current perinatal data base to design and execute a randomized clinical multicenter trial. The on-going research efforts in our Division have led to the development of renowned basic science programs in Perinatal Genetics (including molecular genetics) and Reproductive lmmunology and the services of these laboratories will be made available for participation in MFMU Network protocols. Most importantly, the MFM Division has access to a large number of high-risk and low-risk pregnancies because we provide clinical coverage for four affiliated hospitals with a combined delivery total of greater than 12,000 deliveries per year. Adequate patient numbers for MFMU Network protocols would be expected given the total number of patients which can be approached for enrollment and the cooperative nature of the population. These features, along with our unique geographic region, distinguish the MFM Division at the University of Utah as a productive and successful academic group which will enhance the MFMU Network.

该提案的目的是表明孕产妇司 犹他大学健康科学中心的胎儿医学 (MFM) 成为母胎医学会员的优秀候选人 单位 (MFMU) 网络由国家儿童健康研究所赞助 和人类发展。 MFM部门过去的学术记录 生产力，之前参与多中心试验的成功， 获得合适且合作的患者群体，以及一些 独特的优势使得 MFM 部门能够为 MFMU 带来 凭借强大的网络能力成功开展临床试验 基础科学背景。本提案的具体目标是：（1） 描述该部门的组织结构 MFMU 网络、我们患者群体的人口统计数据以及 各个部门成员的优势； (2) 展示我们的能力 设计并提出多中心试验； (3) 描述特殊的 将向 MFMU 提供该部门的优势 网络。我们已在数个多中心试验中取得成功 过去五年，我们对这些研究的参与将进行详细说明。 我们将描述我们研究工作的组织、患者 可用于研究的人口、研究护士人员配置、临床 我们的计划、计算机化围产期数据库的优势以及 可用于多中心研究的新生儿学服务。 我们提出的 研究题为“单次与每周一次的安全性和有效性” 使用皮质类固醇加速胎儿肺发育 成熟度”，将展示我们使用当前围产期数据的能力 设计和执行随机临床多中心试验的基础。这 我们部门正在进行的研究工作导致了 围产期遗传学领域著名的基础科学项目（包括分子生物学） 遗传学）和生殖免疫学以及这些服务 实验室将可参与 MFMU 网络 协议。最重要的是，MFM 部门可以接触到大量的 高风险和低风险怀孕，因为我们提供临床承保 四家附属医院合计交付总量更大 每年交付超过 12,000 件。 MFMU 的患者数量充足 考虑到患者总数，预计网络协议 可以联系该机构进行注册和合作性质 人口。这些特征，加上我们独特的地理区域， 将犹他大学的 MFM 部门区分为富有成效和 成功的学术团体将增强 MFMU 网络。