MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

母胎医学单位的多中心网络

• 批准号: 6487165
• 负责人: MICHAEL W. VARNER
• 金额: $ 4.06万
• 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/6487165
• 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.

这一建议的目的是表明，产妇司- 犹他州大学健康科学中心的胎儿医学（MFM）是 一个优秀的候选人，成为一个成员的母胎医学 由国家儿童健康研究所赞助的单位（MFMU）网络 和人类发展。 MFM部门过去的学术记录 生产力，先前参与多中心试验的成功， 获得合适和合作的患者群体，以及 独特的优势，使MFM部门能够为MFMU带来 网络的能力，成功地进行临床试验，具有很强的 基础科学背景。这项建议的具体目标是：（1） 说明该司在以下方面的组织结构： MFMU网络，我们的患者人群的人口统计数据，以及 （2）展示我们的能力， 设计并提出多中心试验;（3）描述特殊的 将提供给MFMU的部门的优势 网络我们已经在几个多中心试验中取得了成功， 过去五年，我们将详细介绍我们参与这些研究的情况。 我们将描述我们的研究工作的组织，病人 可用于研究的人群，研究护士人员配备，临床 我们计划的优势，我们的计算机化围产期数据库，以及 可为多中心研究提供生殖医学服务。 我们提出的 研究，题为“单次与每周一次的安全性和有效性 应用皮质类固醇加速胎儿肺发育 成熟”，将证明我们有能力利用我们目前的围产期数据 设计和执行随机临床多中心试验的基础。的 我们部门正在进行的研究工作导致了 著名的围产期遗传学基础科学计划（包括分子 遗传学）和生殖免疫学以及这些服务 将提供实验室参加MFMU网络 协议.最重要的是，MFM部门可以获得大量 高风险和低风险怀孕的风险，因为我们提供临床覆盖 四家附属医院的总交付量超过 每年超过12，000次交付。 MFMU的患者数量充足 考虑到患者总数， 这可以接近登记和合作性质的 人口这些特点，沿着我们独特的地理区域， 区分MFM司在犹他州的大学作为一个富有成效的， 成功的学术团体，这将加强MFMU网络。