NICHD Cooperative Multicenter Neonatal Research Network

NICHD 多中心新生儿合作研究网络

• 批准号: 7104632
• 负责人: IVAN D FRANTZ
• 金额: $ 59.53万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7104632
• 关键词: Lactobacillus; automated medical record system; biotherapeutic agent; clinical research; clinical trials; cooperative study; developmental nutrition; drug screening /evaluation; enteric bacteria; experimental designs; feces analysis; human subject; human therapy evaluation; intestinal mucosa; longitudinal human study; low birth weight infant human; mucosal immunity; necrotizing enterocolitis; neonatal intensive care; neuropsychological tests; newborn human (0-6 weeks); patient oriented research; perinatal; premature infant human

DESCRIPTION (provided by applicant): The Division of Newborn Medicine at the Floating Hospital for Children at Tufts-New England Medical Center (Tufts-NEMC), Tufts University School of Medicine, Boston, is submitting a new application for participation in the NICHD Neonatal Research Network (NRN). This application demonstrates that the Floating Hospital meets and exceeds the criteria for NRN sites as outlined in the RFA. The Floating Hospital's Division of Newborn Medicine has a long history of leadership in multicenter clinical trials, with a superb record for enrollment and follow-up. Members of the Division have been involved in 24 multicenter clinical studies in the past fifteen years. The Principal Investigator, Ivan D. Frantz, III has extensive experience both in design of multicenter trials of his own, as well as participation in those of others. The Division has exceptionally strong research partnerships with Tufts-NEMC's Divisions of Maternal-Fetal Medicine and Genetics. More than 600 infants from a diverse population are admitted annually to the Floating Hospital's 41 bed level III neonatal ICU. Newborn Medicine and Maternal-Fetal Medicine have well-established formal affiliations with hospitals in the area with 19,000 annual births, ensuring a consistent patient base for clinical and translational research. NICU and antepartum support staff have extensive experience with clinical investigation. A full spectrum of multidisciplinary follow-up services for high-risk NICU graduates is provided at The Floating Hospital's Neonatal Follow-Up Clinic. The Division enjoys broad institutional support for clinical research, and the environment offers extraordinary resources for conduct of research, data management, and safety monitoring, including the Tufts-NEMC General Clinical Research Center, which has supported many of the Division's studies. The Division's expertise and judgment in study selection and design is demonstrated by inclusion of an important, innovative and soundly designed concept application. The Floating Hospital's strong clinical services, diverse and stable patient population, experience and leadership in collaborative clinical research, outstanding resources, and strong commitment will be enormous assets to the NRN. This application represents a unique opportunity to strengthen the NICHD Neonatal Research Network through addition of the diverse resources and areas of expertise at the Floating Hospital, thereby advancing our common goal of reducing infant morbidity and mortality.

描述（由申请人提供）：波士顿塔夫茨大学医学院塔夫茨-新英格兰医学中心 (Tufts-NEMC) 儿童浮动医院新生儿医学部正在提交一份加入 NICHD 新生儿研究网络 (NRN) 的新申请。该申请表明，浮动医院满足并超过了 RFA 中概述的 NRN 站点标准。浮动医院新生儿医学部在多中心临床试验方面拥有悠久的领导地位，在入组和随访方面拥有出色的记录。在过去 15 年里，该部门的成员参与了 24 项多中心临床研究。首席研究员 Ivan D. Frantz, III 在设计自己的多中心试验以及参与其他人的多中心试验方面拥有丰富的经验。该部门与 Tufts-NEMC 的母胎医学和遗传学部门有着非常牢固的研究合作伙伴关系。 Floating Hospital 拥有 41 个床位的三级新生儿 ICU 每年收治来自不同人群的 600 多名婴儿。新生儿医学和母胎医学与该地区每年出生 19,000 名新生儿的医院建立了良好的正式联系，确保了临床和转化研究的稳定患者基础。 NICU 和产前支持人员在临床调查方面拥有丰富的经验。浮动医院的新生儿随访诊所为高危 NICU 毕业生提供全方位的多学科随访服务。该部门在临床研究方面享有广泛的机构支持，并且环境为研究、数据管理和安全监测的开展提供了非凡的资源，其中包括塔夫茨-NEMC 普通临床研究中心，该中心为该部门的许多研究提供了支持。该部门在研究选择和设计方面的专业知识和判断力通过纳入重要的、创新的和设计合理的概念应用来证明。浮动医院强大的临床服务、多样化且稳定的患者群体、合作临床研究的经验和领导力、出色的资源以及坚定的承诺将成为 NRN 的巨大资产。该应用程序提供了一个独特的机会，通过增加浮动医院的多样化资源和专业领域来加强 NICHD 新生儿研究网络，从而推进我们降低婴儿发病率和死亡率的共同目标。