Aerosolized PGE1 in Neonatal Pulmonary Hypertension

描述(申请人准备)：候选人，Beena Sood医学博士，是 有兴趣从事新生儿-围产期医学的学术生涯 注重以病人为中心的研究。感兴趣的领域是使用 雾化药物：新生儿、肺部生物学和药理学 肺血管和动脉导管的操作。候选人 在她的团契培训期间一直积极参与研究。这个 韦恩州立大学的机构环境提供了广泛的 提供给应聘者的资源：新生儿--围产期 Hutzel医院和#年儿童医院的医疗服务都很繁忙 密歇根州。职业发展计划包括正式的指导，广泛的 取得临床研究设计和理科硕士学位的课程 统计分析、临床与辅助实验室的开展 以患者为中心的相关研究。索德博士的导师，西萨 尚卡兰，医学博士，是一位著名的新生儿专家，在 涉及多中心临床的临床研究设计 通过NICHD新生儿研究网络进行的试验。她已经确立了 与密歇根州和全国各地的新生儿专家建立合作关系 这将为索德博士提出的研究提供便利。合资企业Aranda医学博士 和V Delaney-Black医学博士，公共卫生硕士将是这项研究的顾问。索德博士建议 前列腺素E_1雾化吸入的临床研究 选择性肺血管扩张剂治疗持续性肺损伤 新生儿高血压(PPHN)。这是研究计划的两个阶段。 最初，雾化PGE1在足月和近距离婴儿中的I期试点研究 PPHN将在密歇根儿童医院进行(已经 正在进行中)与底特律地区的其他医院合作 确定PGEL的适当剂量。在第二阶段，随机化的 前列腺素E_1雾化吸入最佳剂量的对照研究 将对这些单位进行疗效评估。如果有效，一项关于 将雾化PGE1用于新生儿PPHN作为一项多中心研究 提交给NICHD新生儿网络。

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.