NICHD Maternal Fetal Medicine Units Network

描述(申请人提供)：作为该网络的新成员，北卡罗来纳大学MFMU网站已经完成了四项随机临床试验和一项观察性研究；正在对两项试验进行后续研究；并有五项试验正在进行中。我们一直在所有网络网站的招聘总人数中排名前半，并在西班牙裔招聘方面表现出色。作为一个强大的网站，加上我们在临床试验研究和围产期流行病学方面的卓越传统，我们非常适合继续作为该网络的高生产率成员。我们在我们的围产期研究核心中组建了一支由医生、研究员、研究生、研究护士、临床研究助理、实验室工作人员和其他研究人员组成的才华横溢、尽职尽责的团队，这是一个致力于通过最先进的研究了解和改善妊娠结局的研究联盟。核心由完善的基础设施支持，包括临床跟踪系统、数据管理资源和专门的研究服务，如计算机辅助电话访谈设施、NIH临床营养研究中心、全国顶级临床研究中心之一、炎症性疾病综合中心、口腔和系统疾病中心以及妇女健康研究中心。随着Rex Healthcare加入这一应用程序，我们的网站每年有超过13,000名新生儿出生，其中33%的新生儿因母体共病而处于高风险状态，包括药物滥用、胎儿异常、妊娠并发症或早产风险特征，包括多胎妊娠。UNC和WakeMed为我们的产前人口提供了几乎所有的高风险产前诊所和基于医院的护理，因为我们的低风险社区诊所系统配备了使用统一筛查和转诊方案的非产科/妇科医生。这些诊所的病人在北卡罗来纳大学或WakeMed医院分娩。总体而言，WakeMed和UNC的大多数产前患者都很穷：UNC的55%和WakeMed的有医疗补助或自费；UNC的45%和WakeMed的36%有某种形式的私人保险。REX患者群体主要是低风险患者，大多数人都有某种形式的私人保险。雷克斯有一个大型的分娩中心和设施，来自维克县30多家私人诊所的患者可以在这里分娩。我们目前在NIH资助的其他研究中使用了其中的18种做法。与Rex的合作将进一步扩大我们的门诊招聘基础。我们招募的种族和民族多样性很强，42%的白人参与者，29%的西班牙裔美国人和27%的非裔美国人。北卡罗来纳大学和WakeMed有3级新生儿护理病房，Rex有2级托儿所。北卡罗来纳大学今年同时申请加入新生儿研究网络。作为MFMU的一部分，我们的三个合作机构共同带来了超过15年的多站点研究成果、经验丰富的研究人员、最先进的护理设施、稳定的人口、不断增强的计算机化围产期数据库以及致力于卓越的合作研究。

DESCRIPTION (provided by applicant): As a new member of the Network, the UNC MFMU site has completed four randomized clinical trials and one observational study; is conducting follow-up studies for two trials; and has five trials ongoing. We have consistently ranked in the top half of overall recruitment among all network sites and excelled at Hispanic recruitment. This track record as a strong site, coupled with our tradition of excellence in clinical trials research and perinatal epidemiology makes us ideally suited to continue as a highly productive member of the Network. We have assembled a talented and committed team of physicians, research fellows, graduate students, research nurses, clinical research assistants, laboratory staff, and other investigators in our Perinatal Research Core, an alliance of investigators dedicated to understanding and improving pregnancy outcomes through state-of-the-art research. The Core is supported by a well-established infrastructure consisting of clinical tracking systems, data management resources, and specialized research services such as computer assisted telephone interviewing facilities, an NIH Clinical Nutrition Research Center, one of the top General Clinical Research Centers in the nation, a Comprehensive Center for Inflammatory Disorders, the Center for Oral and Systemic Diseases, and the Center for Women's Health Research. With the addition of Rex Healthcare in this application, our sites have more than 13,000 births each year, 33% of which are high-risk by virtue of maternal co-morbidities, including substance abuse, fetal anomalies, pregnancy complications, or preterm birth risk profile, including multiple gestations. UNC and WakeMed provide virtually all of the high-risk prenatal clinic and hospital-based care for our prenatal population because of a system of low-risk community clinics staffed by non-OB/GYNs using uniform screening and referral protocols. Patients from these clinics give birth at UNC or WakeMed. Overall, the majority of prenatal patients at WakeMed and UNC are indigent: 55% at UNC and 64% at WakeMed have Medicaid or are self-pay; 45% at UNC and 36% at WakeMed have some form of private coverage. The Rex patient population is predominately lower risk patients and the majority have some form of private coverage. Rex has a large birthing center and facilities where patients from more than 30 private practices in Wake County give birth. We currently work with 18 of these practices in other NIH-funded research. Affiliation with Rex will further broaden our base for outpatient recruitment. Racial and ethnic diversity in our recruitment has been strong with 42% white participants, 29% Hispanics, and 27% African Americans. UNC and WakeMed have Level 3 neonatal care units, and Rex has a Level 2 nursery. UNC is simultaneously applying to join the Neonatal Research Network this year. Together, our three partner institutions bring more than fifteen years of productive multi-site research, experienced investigators, state-of-the-art care facilities, a stable population, ongoing enhancements of computerized perinatal databases, and commitment to excellence in collaborative research as part of the MFMU.