Aerosolized PGE1 in Neonatal Pulmonary Hypertension

雾化 PGE1 在新生儿肺动脉高压中的应用

• 批准号: 6725523
• 负责人: BEENA G. SOOD
• 金额: $ 12.63万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-01 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6725523
• 关键词: clinical trial phase I; clinical trials; dosage; drug screening /evaluation; human subject; inhalation drug administration; newborn human (0-6 weeks); oximetry; patient oriented research; pediatric pharmacology; postdoctoral investigator; prostaglandin E; pulmonary circulation; pulmonary hypertension; respiratory oxygenation; respiratory therapy; vascular resistance; vasodilators

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.

描述（由申请人准备）：候选人，Beena ood医学博士，是