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 Snchez, 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. Snchez will provide expertise to the NRN on issues in neonatal infectious diseases, a vexing problem among low birth weight infants.
The Eunice Kennedy Shriver NICHD Neonatal Research Network (NRN) has been established to conduct multicenter, interventional, and observational clinical studies in neonates, including those who are preterm and of low birth weight. The goal of these studies is to reduce infant morbidity and mortality and promote healthy outcomes in high risk infants and children.
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