MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

母胎医学单位的多中心网络

• 批准号: 6182550
• 负责人: RONALD WAPNER
• 金额: $ 112.08万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 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/6182550
• 关键词: cerebral hemorrhage; chemoprevention; clinical research; cooperative study; corticosteroid analog; dexamethasone; drug screening /evaluation; embryo /fetus chemotherapy; embryo /fetus membrane; female; hormone therapy; human pregnant subject; human subject; human therapy evaluation; mother /infant health care; perinatal; pregnancy immunology; premature infant human; premature labor; prenatal care; prenatal diagnosis; pulmonary surfactants; respiratory distress syndrome of newborn; tocolytic agents; ultrasonography

A "concept" protocol for evaluating the efficacy of antenatal steroids following preterm premature rupture of membranes (PT-PROM) is submitted to demonstrate the capabilities of the investigators in protocol development. This protocol is a randomized double blind controlled study in which patients presenting with PROM will be stratified into two groups one at 24-28 weeks and the other at 29-32 or 34 weeks. Data are provided from 60 PT-PROM patients recently cared for at Thomas Jefferson University Hospital (TJUH) to provide insight into potential study problems. The key issues to successfully participate in the collaborative research network, aside from the "concept" protocol, are the resources, personnel, and experience of the physician research team. The Jefferson Medical College Clinical Center (JMC-CC) has recently been formed by a merger of the two largest perinatal centers in the Philadelphia area: Thomas Jefferson University Hospital and Pennsylvania Hospital. This center formed under the aegis of Jefferson Medical College provides a large single entity for clinical care, research and education. The JMC-CC is applying to perform collaborative research as a participant in the cooperative Multicenter Maternal-Fetal Medicine (MFM) Network. This academic center will provide access to a population of over 6500 deliveries per year of which over 3000 are patients of the hospital faculty or clinic. There is a total available faculty of 13.5 Maternal- Fetal Medicine subspecialists. The participating physicians are academically productive and have participated in multiple previous multicenter studies. Five MFM subspecialists will take primary responsibility for network protocols. These physicians will have a minimum of 20% protected time for participation in the study and the principal investigator will have 40%. The JMC-CC has an existing structure to perform clinical research. This includes three full-time research nurses, a departmental obstetrical data system, a full-time physician data manager, and a data entry clerk. All patients of the JMC-CC are available to participate in research projects and a system of active chart surveillance is in place to maximize enrollment. Thirty to 50% of the patient population is high-risk and approximately 95% of the patients receive their prenatal care within the center. The JMC-CC has extensive experience and expertise in antenatal testing and intrapartum diagnoses and has one of the country's largest antenatal testing and ultrasound units. Additional assets include perinatal pathology, genetics, a fetal cardiology and physiology unit, and a reproductive immunology laboratory. The JMC-CC is supported by one of the largest neonatal divisions in the country which cares for over 2300 neonates per year and is an active participant in national multicenter trials. The center has an active community outreach network with over 40,000 deliveries under its direction.

评估产前类固醇功效的“概念”方案 早产儿胎膜早破 (PT-PROM) 提交给 展示研究人员在方案开发方面的能力。 该方案是一项随机双盲对照研究，其中 患有 PROM 的患者将被分为两组，一组在 24-28 周，另一个在 29-32 或 34 周。数据来自 60 最近在托马斯杰斐逊大学接受护理的 PT-PROM 患者 医院 (TJUH) 提供对潜在研究问题的洞察。关键 成功参与协作研究网络的问题， 除了“概念”协议外，还有资源、人员和 医师研究团队的经验。 杰斐逊医学院临床中心 (JMC-CC) 最近已 由两个最大的围产中心合并而成 费城地区：托马斯·杰斐逊大学医院和宾夕法尼亚州 医院。该中心在杰斐逊医学院的支持下成立 为临床护理、研究和教育提供了一个大型的单一实体。 JMC-CC正在申请作为参与者进行合作研究 在多中心母胎医学 (MFM) 合作网络中。这 学术中心将为超过 6500 名人口提供服务 每年分娩，其中超过3000名是该医院的患者 学院或诊所。共有 13.5 名母亲可用的教员 胎儿医学亚专科。参与的医生有 学术成果丰硕，并参加过多项先前的活动 多中心研究。五名 MFM 专科医生将接受初级教育 网络协议的责任。这些医生至少有 20% 的受保护时间用于参与研究和校长 调查员将拥有40%。 JMC-CC 的现有结构是 进行临床研究。这包括三名全职研究护士， 科室产科数据系统、专职医师数据 经理和数据录入员。 JMC-CC 的所有患者均可参加 参与研究项目和活跃图表系统 实行监督以最大限度地提高入学率。百分之三十到百分之五十 患者群体属于高危人群，约 95% 的患者 在中心内接受产前护理。 JMC-CC 拥有广泛的 产前检测和产时诊断的经验和专业知识 并拥有全国最大的产前检测和超声检查中心之一 单位。其他资产包括围产期病理学、遗传学、胎儿 心脏病学和生理学单位以及生殖免疫学实验室。 JMC-CC 得到了世界上最大的新生儿科之一的支持 每年照顾超过 2300 名新生儿的国家，是一个活跃的国家 国家多中心试验的参与者。该中心拥有活跃的 社区外展网络已交付超过 40,000 件货物 方向。