NICHD Cooperative Multicenter Neonatal Research Network - (UG1) Ohio State

 描述(由申请人提供)：这份提案是国家儿童医院(NCH)和俄亥俄州立大学(OSU)新生儿科再次申请参加多中心临床项目，尤尼斯·肯尼迪·施莱弗NICHD新生儿研究网络(NRN)。NCH-OSU自2011年以来一直是NRN的成员。医学博士巴勃罗·Sánchez、医学博士苏达坎·加德切拉和医学博士娜塔莉·迈特尔分别是首席调查员(PI)、候补PI和后续PI。Maitre博士是NRN团队的一名重要成员。她于2015年7月加入NCH-OSU的新生儿科，在范德比尔特大学期间在高危婴儿的评估和随访方面拥有丰富的经验。她的出席和贡献极大地加强了我们的后续计划。作为NRN临床中心，NCH-OSU拥有必要的学术、研究和临床基础设施，将确保NRN研究的持续卓越表现。俄亥俄州立大学NCH-OSU的新生儿科一直致力于临床研究，在这方面，它得到了俄亥俄州立大学儿科及其临床设施、NCH和俄亥俄州立大学韦克斯纳医学中心的大力支持，与该RFA相关的临床研究将继续在该中心进行。重要的是，随着这份意见书的提交，将增加第三个SIT，即河滨卫理公会医院(RMH)的NCH NICU，该设施号称拥有哥伦布最大的先天分娩服务。此外，产科。俄亥俄州立大学是NICHD母婴医学部(MFMU)的14个中心之一，OSU母婴医学部和NCH之间在所有级别的临床护理和研究中都存在着强有力的合作。这一伙伴关系确保了用于临床研究的不同患者的持续来源。NCH-OSU在NRN内有经过证明的跟踪记录，其组织良好的临床研究计划证明了这一点，符合条件的婴儿同意进行随机试验的比例很高，而且在进行研究方面表现出色。PI在多中心随机临床试验的执行方面拥有丰富的经验。通过获得新生儿学和儿科传染病委员会认证，S博士将在新生儿传染病问题上为NRN提供专业知识，新生儿传染病是低出生体重婴儿的一个令人头疼的问题。

 DESCRIPTION (provided by applicant): This proposal is a reapplication from the Division of Neonatology at Nationwide Children's Hospital (NCH) and The Ohio State University (OSU) to participate in the multi-center clinical program, the Eunice Kennedy Shriver NICHD Neonatal Research Network (NRN). NCH-OSU has been a member of the NRN since 2011. Pablo Sánchez, MD, Sudarchan Jadcherla, MD, and Nathalie Maitre, MD are the Principal Investigator (PI), Alternate PI, and Follow-up PI, respectively. Dr. Maitre is an important addition to the NRN team. She joins the Neonatology Division at NCH-OSU in July 2015 and has extensive experience in the assessment and follow- up of high risk infants while at Vanderbilt University. Her presence and contribution enhances our follow-up program significantly. As an NRN clinical center, NCH-OSU has the necessary academic, research and clinical infrastructure already in place that will assure continued excellence in the performance of NRN studies. The Neonatology Division at NCH-OSU has demonstrated a strong commitment to clinical research, and in this endeavor, it has the strong support of the OSU Pediatric Department and its clinical facilities, NCH and The Ohio State University Wexner Medical Center where the clinical studies pertaining to this RFA will continue to be performed. Importantly with this submission, a third sit will be added, namely the NCH NICU at Riverside Methodist Hospital (RMH), a facility that boasts the largest inborn delivery service in Columbus. In addition, the Obstetric Dept. of OSU is one of 14 centers of the NICHD Maternal-Fetal Medicine Units (MFMU), and strong collaboration between the OSU MFMU and NCH exists at all levels of clinical care and research. This partnership assures a continued source of diverse patients for clinical studies. NCH-OSU has a proven track record within the NRN, as evidenced by its well organized clinical research program with a high percentage of eligible infants consented for randomized trials and excellence in conducting the studies. The PI has extensive experience in the performance of multicenter, randomized clinical trials. By being board certified in both Neonatology and Pediatric Infectious Diseases, Dr. Sánchez will provide expertise to the NRN on issues in neonatal infectious diseases, a vexing problem among low birth weight infants.