This proposal reviews evidence to support that Brown University is a productive center for cutting edge clinical investigation of critically ill newborns and justifies continuation as a member of the Neonatal Research Network (NRN). The Brown NRN Center is based at a single, large, perinatal center, Women & Infants Hospital (WIH). WIH is the only regional center for high-risk Obstetrics and Neonatal Intensive Care in the state of Rhode Island, and is the hub of an exceptionally well-organized region for perinatal care, which includes all of Rhode Island, southeastern Massachusetts and a portion of eastern Connecticut. The regional organization results in large cohorts of preterm and term infants cared for and available for clinical research in the WIH Neonatal Intensive Care Unit. The Division of Neonatal-Perinatal Medicine is academically oriented and has a long-standing and deep commitment to maintain a robust perinatal research program in addition to high quality teaching and clinical care. The research program has been developed with varied domains that encompass clinical research, laboratory based initiatives, behavioral health and investigation of developmental follow-up. The research enterprise is strengthened through collaborative links with the Warren Alpert Medical School and Hasbro Children's Hospital. Within this frame work, the Brown NRN Center has been productive over the past 4 years with regards to both patient recruitment and investigator contribution to academic productivity. Enrollment into studies at the Brown NRN Center ranks in the top half of all NRN centers except for one trial. Trials are performed with relatively few protocol violations, carefully collected data and in a timely manner with few data edits. Our Follow-up team carefully tracks patients and uses all available resources to have patients come for follow-up. The Brown NRN Investigators are well-established and provide expertise in specific areas that enhance NRN studies. The Principal Investigator is Abbot Laptook whose research interest and expertise is neuroprotection with a special emphasis on therapeutic hypothermia and is reflected in his effort in the NRN. The Alternate Principal Investigator is Martin Keszler who has expertise in respiratory physiology, pulmonary mechanics and pulmonary morbidities of prematurity. The Follow-up Investigator is Betty Vohr who is a leader in the area of neuro-development of high-risk newborns. In addition, Dr. Vohr plays a pivotal role for all NRN Follow-up Programs. She is responsible for maintenance of pre-specified standards among the Follow-up examiners which is one of the many characteristics that distinguish the NRN from other collaborative groups. Investigators from the Brown NRN Center have submitted multiple protocols to the NRN over the last funding cycle for scientific review. These protocols focus on important, contemporary issues in the care of critically ill newborns. In summary, the Brown NRN Center has the patient population needed for studies, an accomplished investigative team and a strong performance record to merit continued participation in the Neonatal Research Network.
The goal of the National Institutes of Child Health and Human Development Neonatal Research Network is to answer important questions in the care and management of critically ill newborns whether they are preterm or term infants. The Brown Neonatal Research Network (NRN) Center has been a contributing member of the NRN, has the infra-structure in place to perform interventional and observational studies and function collaboratively under a mult-center cooperative agreement. Results of NRN investigations have impacted important standards of neonatal care and have expanded the evidence base regarding management of high- risk, sick newborn infants.
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