The sole objective of this application being submitted by the University of Miami is to achieve continued participation in the NICHD Collaborative Neonatal Research Network. This center has been an active and contributing member of the network for the last fifteen (15) years, being one of he original sites selected in the initial competition. Over the last 25 years, the University of Miami has participated successfully in several large, multicenter, collaborative, clinical trails so that the principal investigator and his co-investigators have a long history of successful collaboration. This experience will be invaluable in future protocol design and implementation, quality control, data management, and data analysis. This center has the patient population, the resources and the committed staff to ensure a high level of clinical and scientific contribution. The research and clinical faculty of the Division of Neonatology are particularly interested in the epidemiologic approach to improving the acute care and the long-term neuro-developmental and behavioral outcome of infants who are premature, immature or acutely ill in the immediate newborn period. Because neonatology is such a young subspecialty, treatment modalities are often based on individual impressions and isolated experiences, which do not effectively translate into efficacy and safety data. Neonatology's history is speckled with severe therapeutic misadventures that were based on good faith rather than scientific fact. The hyperoxia management of newborns in the 1950's resulting in epidemic blindness, and the chloramphenicol induced gray baby syndrome, are only two examples of why a clinical research network of experienced investigators with expertise in neonatal care and collaborative research is essential to improve the safety, health care and long-term outcome of infants born at-risk due to disease or immaturity. The University of Miami has enjoyed being a member of this scientific collaboration over the last 15 years, has actively participated and contributed to significant advances in care based on the findings of several clinical trials successfully designed, initiated, and in most cases completed by the network. This center has several major strengths that should support its inclusion in the neat cycle of this research network. These include a large, clinical population which represents diverse ethnicity and socioeconomics, an academic faculty with international recognition for their clinical and research experience and expertise, a state-of the-art nursery, a large multidisciplinary follow-up program, extensive and successful experiences in conducting clinical trials, and a supportive academic and clinical administration. This center's level of involvement in the network over the last 15 years, and its contributions to the network clearly forecast its successful participation over the neat 5-year cycle of the NICHD Neonatal Research Network.
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