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

NICHD 合作多中心新生儿研究网络 - (UG1) 俄亥俄州立大学

• 批准号: 9078918
• 负责人: Pablo J Sanchez
• 金额: $ 28.35万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9078918
• 关键词: Area; Caring; Child; Childhood; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Consent; Dedications; Discipline of obstetrics; Disease; Enrollment; Ensure; Evaluation; Funding; Future; Goals; Gold; Hospitals; Individual; Infant; Infection; Institution; Intervention; Joints; Lead; Leadership; Low Birth Weight Infant; Medical center; Medicine; Methodist Church; Multi-Institutional Clinical Trial; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatology; Nurseries; Observational Study; Ohio; Outcome; Patients; Pediatric Hospitals; Performance; Principal Investigator; Protocols documentation; Randomized Clinical Trials; Reapplication; Research; Research Infrastructure; Resources; Role; Safety; Sepsis; Services; Source; Structure; System; Treatment Efficacy; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Work; antimicrobial; clinical care; clinical infrastructure; clinical research site; college; data acquisition; design; early onset; experience; feeding; fetal; fetal medicine; follow-up; high risk infant; improved; infant morbidity/mortality; man; member; neonatal care; neonate; pediatric department; perinatal medicine; programs; public health relevance; randomized trial

 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.

 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立大学 (OSU) 重新申请参加多中心临床项目，尤尼斯·肯尼迪·施赖弗 (Eunice Kennedy Shriver) NICHD 新生儿研究网络 (NRN)。 NCH-OSU 自 2011 年起成为 NRN 成员。Pablo Sánchez（医学博士）、Sudarchan Jadcherla（医学博士）和 Nathalie Maitre（医学博士）分别是首席研究员 (PI)、候补 PI 和后续 PI。 Maitre 博士是 NRN 团队的重要补充。她于 2015 年 7 月加入 NCH-OSU 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。她的出现和贡献极大地增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。 NCH-OSU 新生儿科表现出了对临床研究的坚定承诺，在这一努力中，它得到了 OSU 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俄亥俄州立大学韦克斯纳医学中心进行。重要的是，本次提交后，将增加第三个医院，即河滨卫理公会医院 (RMH) 的 NCH 新生儿重症监护室，该机构拥有哥伦布最大的分娩服务。此外，俄勒冈州立大学产科是 NICHD 母胎医学单位 (MFMU) 的 14 个中心之一，俄勒冈州立大学 MFMU 和 NCH 在临床护理和研究的各个层面都存在着强有力的合作。这种伙伴关系确保了临床研究的不同患者的持续来源。 NCH-OSU 在 NRN 内拥有良好的记录，其组织良好的临床研究项目证明了这一点，有很高比例的合格婴儿同意参加随机试验，并且在开展研究方面表现出色。 PI 在进行多中心、随机临床试验方面拥有丰富的经验。通过新生儿学和儿科传染病委员会认证，Sánchez 博士将为 NRN 提供有关新生儿传染病问题的专业知识，新生儿传染病是低出生体重婴儿中的一个棘手问题。