NICHD Neonatal Research Network (NRN)

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PROJECT SUMMARY/ABSTRACT This proposal is a renewal application from the Division of Neonatology at Nationwide Children’s Hospital (NCH) and The Ohio State University (OSU) to participate with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under a cooperative agreement (RFA: HD-16-020) in an ongoing multicenter clinical research program entitled the Neonatal Research Network (NRN). NCH/OSU was selected in 2011 to become one of 18 academic centers of the NRN. In 2016, NCH/OSU along with an additional affiliated neonatal intensive care unit (NICU) at Riverside Methodist Hospital (RMH) was again selected as one of the 15 centers that currently comprise the NRN. The Division of Neonatology has demonstrated a strong commitment to the NRN and will continue to support and enhance this network. Pablo Sánchez, MD, Jonathan Slaughter, MD, MPH, and Kristen Benninger, MD, MSc, are the Principal Investigator (PI), Alternate PI, and Follow-up PI, respectively. Dr. Sánchez has extensive experience in the performance of multicenter, randomized clinical trials. By being board certified in both Neonatology and Pediatric Infectious Diseases, he will provide expertise to the NRN on issues in neonatal infectious diseases and antimicrobial stewardship, vexing problems in the NICU. Dr. Slaughter has extensive experience in clinical research including clinical trial and advanced observational study design, while Dr. Benninger studies the long term outcomes of opioid-exposed infants. The Specific Aim of this proposal is to conduct multicenter clinical trials and observational studies in neonatal medicine in order to reduce infant morbidity and mortality and promote healthy outcomes. With the strong support of the Pediatric Department and Hospitals, NCH-OSU-RMH has the necessary academic and innovative clinical and research infrastructure to ensure continued excellence in the performance of NRN studies. Our Neonatology Division has a long-standing dedication to improving patient outcomes with a strong focus on health equity. We have developed innovative signature clinical programs in extreme prematurity, bronchopulmonary dysplasia, infant feeding, neonatal infectious diseases/antimicrobial stewardship, acute kidney injury, neonatal cardiology, and neonatal neurology that have positively impacted patient outcomes and positioned us as a region- al/national/international referral and consultation center. In addition, the Obstetric Dept. at OSU is one of 12 centers of the NICHD Maternal-Fetal Medicine Units (MFMU), and strong collaboration exists between the OSU MFMU and NCH at all levels of clinical care and research. This ongoing partnership ensures a continued source of diverse patients for clinical studies. NCH-OSU-RMH has a proven track record within the NRN, as evidenced by its well organized clinical research program with a substantial percentage of eligible infants consented for randomized trials and excellence in study conduct and data acquisition. Follow-up of study infants is integrated within the large Follow-up Program at NCH, and follow-up rates of these infants remain excellent with substantial departmental and divisional support.