NICHD Cooperative Multicenter Neonatal Research Network - Utah Center

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PROJECT SUMMARY/ABSTRACT The goal of this application is for the University of Utah Clinical Center to achieve renewal as a research site in the 2023-2030 Neonatal Research Network (NRN). The Utah Center is an active participant in the NRN with a strong track record in patient recruitment, NRN committee activities, and involvement in design and submission of several past and on-going NRN study protocols. In addition, the Utah Center has continued to actively participate in several large, non-NRN, multi-center randomized trials. The current proposal includes a focus on enhancing rigor and reproducibility, allowing non-network investigators to submit proposals and participate in Network studies, enhancing data sharing, and increasing diversity in populations studied. The Utah Center Principal Investigator, Dr. Robin Ohls, leads the NHLBI-funded NRN Darbe Study, and is a multi-PI on the Darbe-KIDS 5-year follow up proposal. She has past and on-going participation in development, design, manuscript writing, and oversight as PI and steering committee member for many NRN trials. The alternate PI, Dr. Mariana Baserga, is an active member of the Darbe and Open Network Steering Committees, and a site PI for a number of seminal, non-NRN trials. Our co-PI, Dr. Tim Bahr, has joint appointments with IHC and the University of Utah, and will lead studies and NRN activities at two of our IHC sites. Our network of five study sites, our collaboration with the Utah Maternal-Fetal Medicine Unit (MFMU) Network, and our experienced research infrastructure makes our Center uniquely qualified to carry out NRN trials. Specific strengths of the Utah Center includes 1) established expertise in design, implementation and management of multi-center randomized trials; 2) productive collaborative contributions to over 20 large randomized trials over the past decade both within and outside the NRN; 3) past and current collaborative research studies within the University of Utah and Intermountain Healthcare consortium; 4) productive research collaboration with Utah MFMU sites and faculty; 5) the Utah Center Neonatal Follow-Up Program’s proven track record with over 90% follow-up rates for current NRN studies and recent non-NRN multi-center trials; 6) documented support from senior leadership across both the University of Utah Health Sciences Center and Intermountain Healthcare, including Medical Directors of the NICUs and MFMU sites at all participating hospitals. With the leadership of Dr. Ohls, the University of Utah has established productivity as a clinical trial site. An established research infrastructure, strong Neonatal Follow-Up program, and collaborative activities across a widespread community are major factors supporting renewal of the Utah Center as a Neonatal Research Network site.