Aerosolized PGE1 in Neonatal Pulmonary Hypertension

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DESCRIPTION (prepared by applicant): The candidate, Beena Sood MD, is interested in pursuing an academic career in Neonatal-Perinatal medicine with the focus on patient oriented research. The areas of interest are the use of aerosolized medications I newborn, pulmonary biology, and pharmacologic manipulation of the pulmonary vasculature and ductus arteriosus. The candidate has been actively involved in research during her fellowship training. The institutional environment at the Wayne State University offers extensive resources available to the candidate The Division of Neonatal-Perinatal Medicine has a busy service both at Hutzel Hospital and Children's Hospital of Michigan. The career development plan includes formal mentorship, extensive coursework leading to a Master's of Science degree in Clinical Research Design and Statistical Analysis, conduct of clinical and complementary laboratory research related to the patient-oriented research. Dr. Sood's mentor, Seetha Shankaran, MD, is a renowned neonatologist with extensive experience in clinical research study design involved in several Multi center clinical trials through the NICHD Neonatal Research Network. She has established collaborative relationships with neonatologists throughout Michigan and the U.S. that will facilitate the studies proposed by Dr. Sood. JV Aranda MD, PhD and V Delaney-Black MD, MPH will be Consultants on the study. Dr Sood proposes a clinical trial for the use of aerosolized prostaglandin E1 (PGE1) as a selective pulmonary vasodilator in the treatment of persistent pulmonary hypertension (PPHN) in the newborn. T are two phases of the research plan. Initially, a phase I pilot study of aerosolized PGE1 in term and near- infants with PPHN will be conducted at the Children's Hospital of Michigan (already under way) in collaboration with other hospitals in the Detroit area to establish the appropriate dosing of PGEl. In the second phase, a randomized controlled study of the optimum dose of aerosolized Prostaglandin E1 (PGE1) in the units will be conducted to evaluate efficacy. If effective, a proposal for using aerosolized PGE1 in neonatal PPHN as a multicenter study will be submitted to the NICHD Neonatal Network.