The Specific Aim of this application is for the University of Utah Clinical Center to achieve successful entry into the NICHD Neonatal Research Network (NRN) for the 2016-2021 cycle. The Utah Center was previously an active NRN participant during the 2006-2011 with strong participation in patient recruitment, NRN committee activities, and involvement in design and submission of several past or on-going NRN study protocols. Though currently not an active NRN Center, the Utah Center has continued to actively provide neonatal follow-up for several on-going studies, including 6-7 year follow-up for SUPPORT. The Utah Center has continued active participation in several large, non-NRN, multi-center randomized trials. The Principal Investigator, Dr. Bradley A. Yoder, has past and on-going participation in development, design manuscript writing, and oversight as PI and/or steering committee member for many of these non-NRN trials. The current proposal includes an expanded number of Utah Neonatal Intensive Care Unit (NICU) sites; in line with centers that have been active members of the Utah Maternal-Fetal Medicine Unit (MFMU) Network for the past 20 years. The Utah Center now includes 5 sites with 250 NICU beds and over 4,000 NICU admissions per year; representing nearly 90% of all Utah NICU care and almost 100% of all ELGAN/ELBW infants. Specific strengths of the Utah Center include 1) a population base unique from most other NRN Centers including a relatively high socioeconomic profile and a high proportion of non-Hispanic Caucasians; 2) established expertise in design, management, and analysis of multi-center randomized trials; 3) productive collaborative contributions to over 15 large randomized trials over the past decade; 4) past and current collaborative research studies within the University of Utah and Intermountain Healthcare consortium; 5) experienced research staff and support infrastructure including University of Utah Center for Clinical and Translational Science, Pediatric Pharmacology Program, and Institute of Women's and Child research; 6) productive research collaboration with Utah MFMU sites and faculty; 7) an enhanced Neonatal Follow-Up Program now integrated into the Department of Pediatrics; and 8) documented support from senior leadership across both the University of Utah Health Sciences and Intermountain Healthcare, including Medical Directors of the NICUs and MFMU sites at all participating hospitals. With the leadership of Dr. Yoder, 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 wide spread community, coupled with the highly successful Utah MFMU are major factors positioning the Utah Center for selection as a NRN study site.
Survival of all neonates has dramatically improved, particularly those at less than 1,000 grams. Proven, cost- effective approaches to further reduce significant morbidities are essential to survivors' long-term health and to society. Large multi-center trials with varied ethnic-racial-socioeconomic background are necessary for outcome validation and generalizability. The Utah Center is ready to be a leading member of the NICHD Neonatal Research Network, the world's premier neonatal clinical trials group.
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