NICHD Maternal Fetal Medicine Units Network

NICHD 母胎医学单位网络

• 批准号: 7102918
• 负责人: GEORGE R. SAADE
• 金额: $ 50.28万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-15 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7102918
• 关键词: automated medical record system; clinical research; clinical trials; cooperative study; corticosteroids; drug screening /evaluation; embryo /fetus disorder; experimental designs; human subject; human therapy evaluation; neonatal intensive care; patient oriented research; perinatal; pregnancy; prenatal care; prenatal diagnosis; women' s health

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the required elements to actively participate in the Cooperative Multicenter MFMU Network. The PI, George Saade, and the alternate PI, Gary Hankins, bring extensive experience in study design, recruitment, data analysis, and publications from several NIH multisite clinical trials (First and Second Trimester Evaluation of Risk of Aneuploidy, Beneficial Effects of Antenatal Magnesium Sulfate Study, Twin-Twin Transfusion Syndrome Trial, Vaginal Ultrasound Cerclage Trial, Stillbirth Collaborative Research Network, Obstetric-Fetal Pharmacology Research Units Network, Genomic/Proteomic Network for Premature Birth Research). We achieve successful patient recruitment/retention through use of the Ob/Gyn Departments's broad Regional Maternal & Child Health Program (RMCHP). The RMCHP provides prenatal care to over 11,000 multiethnic pregnant women a year. All RMCHP clinics follow protocols set by the Maternal-Fetal Medicine Division, and all antepartum and intrapartum patients are under Departmental control. Our clinical infrastructure and patient population make us well prepared to participate in the Network as we deliver over 5,000 high-risk pregnancies a year, more than 90% receiving prenatal care in our system. The Department's Electronic Medical Record System (EMR) captures antepartum and intrapartum data, entered on-line and readily available to authorize research personnel for query as well as automatic notification. The EMR and policies/procedures have been successfully adapted to maximize our research productivity compared with other collaborating sites. The Department's team of dedicated research nurses and coordinators (Chairman's Research Division [CRD]) and the Tissue BioBank, both under the direction of the PI, have broadened efficiency in clinical investigations. Other key personnel in this application, including Garland Anderson, Chair of our Department as well as the current MFMU Network, Janet Brandon, CRD Nursing Director, and Joan Moss, CRD Coordinator, bring extensive experience and expertise to the team. The excellent and prolific collaboration between PI and alternate PI, who is also the MFM Division Director and RMCHP Medical Director, offers further benefit and efficacy to the Network. Our Department has a productive and well-funded basic science research group, with expertise in many areas of relevance to the RFA. Finally, we have well-established collaborative ties with our University's Divisions of Neonatology, Genetics, Perinatal Pathology, Clinical Laboratory, and Radiology. At all levels, UTMB emphasizes research in general, with multiple core facilities available to the Network including the GCRC, and obstetrical research in particular (our Department ranks 9th in NIH funding nationally, and 1 in Texas). Our concept protocol compares the efficacy and safety of single versus multiple courses of antenatal corticosteroids. We accept the RFA's capitation and participatory stipulations and stand ready to contribute as a productive member of the Network.

描述（由申请人提供）：德克萨斯大学医学分支机构（UTMB）具有积极参与合作多中心MFMU网络所需的要素。 The PI, George Saade, and the alternate PI, Gary Hankins, bring extensive experience in study design, recruitment, data analysis, and publications from several NIH multisite clinical trials (First and Second Trimester Evaluation of Risk of Aneuploidy, Beneficial Effects of Antenatal Magnesium Sulfate Study, Twin-Twin Transfusion Syndrome Trial, Vaginal Ultrasound Cerclage Trial, Stillbirth Collaborative Research网络，产科狂药理学研究单位网络，用于早产研究的基因组/蛋白质组学网络）。我们通过使用OB/GYN部门广泛的区域孕产妇健康计划（RMCHP）实现了成功的患者招聘/保留。 RMCHP每年为11,000多名多民族孕妇提供产前护理。所有RMCHP诊所均遵循母亲 - 狂热医学司设定的方案，所有的动力和全部患者均受到部门控制。我们的临床基础设施和患者群体使我们准备参加该网络，因为我们每年进行5,000多次高危妊娠，超过90％的人在系统中获得产前护理。该部门的电子医疗记录系统（EMR）捕获了天气动物和产前数据，在线输入并随时可用，以授权研究人员查询以及自动通知。与其他协作站点相比，EMR和政策/程序已成功地适应了我们的研究生产率。该部门的专门研究护士和协调员（主席研究部[CRD]）和PIS Biobank的团队在PI的指导下都扩大了临床研究的效率。本申请中的其他关键人员，包括我们部门主席的Garland Anderson以及现任的MFMU网络，CRD护理总监Janet Brandon和CRD协调员Joan Moss为团队带来了丰富的经验和专业知识。 MFM部门总监兼RMCHP医疗总监Pi和替代Pi之间的出色而多产的合作为网络提供了进一步的好处和功效。我们的部门拥有一个富有成效的基础科学研究小组，在与RFA相关的许多领域具有专业知识。最后，我们与大学的新生儿学，遗传学，围产期病理学，临床实验室和放射学的分歧建立了良好的合作关系。 UTMB在各个层面上都强调了一般的研究，该网络包括GCRC在内的多个核心设施，尤其是产科研究（我们的部门在全国范围内排名第9，在德克萨斯州排名第1）。我们的概念协议比较了产前皮质类固醇的单一疗程与多个课程的功效和安全性。我们接受RFA的角色和参与式规定，并准备作为网络的富有成效成员做出贡献。