The primary objective of this application by the University of Miami is for continued participation in the third cycle of the Cooperative Multicenter Neonatal Research Network. The goal of the network, which is currently made up of 12 university neonatal centers is to investigate the safety and efficacy of treatment and management strategies in the care of newborn infants, particularly those of low-birth-weight. It is hoped that this established, on-going network will facilitate such research efforts by providing large populations of mothers and infants available for study and an established research team ready to implement multiple projects simultaneously. The University of Miami has actively participated in this network for the past 10 years providing expertise, leadership and a cooperative spirit to enhance the network's goals. The Division of Neonatology has a large, diverse, multi-cultural population, outstanding clinical, laboratory and research facilities, as well as competent and dedicated personnel. There is a long history of successful participation in multicenter clinical trials as well as individual investigator initiated projects. Previous major collaborative clinical trials have included participation in the administration of prenatal glucocorticoids to prevent respiratory distress syndrome (NHLBI), the high frequency ventilation study (NHLBI) and the infant health and development program (Robert Wood Johnson, NICHD, MCH, Pew Foundation). Although the normal newborn birth population has decreased significantly over the last several years, there has been little effect on the neonatal special care population. This is due to successful triage of complicated, high-risk mothers as well as increased referrals of very small, immature infants from multiple level II units in the district and additional referrals from the Caribbean, Central and South America. Hence, the program draws mothers and infants from an area encompassing over 40,000 deliveries per year. The staff of the neonatal special care center numbers over 250 and includes full-time neonatal respiratory therapists and neonatal pharmacists, as well as nurses, nurse practitioners, clinical attendings, fellows, residents and neonatologists. There are eight board certified and 1 board eligible neonatologists within the program who have expertise in cardio-pulmonary physiology, developmental medicine, hematology, immunology and infectious disease, central nervous system, and the effects of substance abuse on the fetus and newborn. A very large, comprehensive multidisciplinary clinical follow-up and intervention program is directed by the P.I. of this submission. In addition to its clinical commitment to this project, over the last several years the University has designed and finished a large clinical and office area for this project. Ground was broken within the last month for a 12 story pediatric research tower on the medical campus with specific space allocated to the on-going implementation of this research project, both clinically and administratively. The University of Miami has made a major commitment to this important clinical network and is sincere in its effort to continue this collaboration over the next 5 year cycle, attempting to address complex and important advances in the diagnosis and treatment of the newborn.
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