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

 描述（由申请人提供）：本提案是全国儿童医院（NCH）新生儿科和俄亥俄州州立大学（OSU）参与多中心临床项目Eunice Kennedy Shriver NICHD新生儿研究网络（NRN）的再次申请。NCH-OSU自2011年以来一直是NRN的成员。巴勃罗Sánchez，MD、Sudarchan Jadcherla，MD和Nathalie Maitre，MD分别是主要研究者（PI）、替代PI和随访PI。Maitre博士是NRN团队的重要成员。她于2015年7月加入NCH-OSU的新生儿科，并在范德比尔特大学期间对高危婴儿的评估和随访拥有丰富的经验。她的出席和贡献大大加强了我们的后续计划。作为NRN临床中心，NCH-OSU已经具备必要的学术，研究和临床基础设施，这将确保NRN研究的持续卓越表现。NCH-OSU的新生儿科部门已证明对临床研究的坚定承诺，在这奋进，它得到了OSU儿科部门及其临床机构、NCH和俄亥俄州州立大学Wexner医学中心的大力支持，将继续进行与该RFA相关的临床研究。重要的是，这次提交，第三个地点将增加，即NCH新生儿重症监护室在滨江卫理公会医院（RMH），一个设施，拥有最大的先天性分娩服务在哥伦布。此外，产科部门。OSU是NICHD母胎医学单位（MFMU）的14个中心之一，OSU MFMU和NCH之间的密切合作存在于临床护理和研究的各个层面。这种合作关系确保了临床研究的多样化患者的持续来源。NCH-OSU在NRN内有着良好的记录，其组织良好的临床研究计划证明了这一点，有很高比例的合格婴儿同意进行随机试验，并且在进行研究方面表现出色。PI在开展多中心、随机临床试验方面具有丰富的经验。通过获得新生儿和儿科传染病委员会认证，桑切斯博士将为NRN提供新生儿传染病问题的专业知识，这是低出生体重婴儿中令人烦恼的问题。

 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.