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: 6620356
• 负责人: BEENA G. SOOD
• 金额: $ 12.34万
• 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/6620356
• 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 Sood MD是 有兴趣在新生儿-围产期医学领域从事学术事业， 以患者为导向的研究。感兴趣的领域是使用 雾化药物I新生儿、肺生物学和药理学 肺血管和动脉导管的操作。候选 在她的奖学金培训期间一直积极参与研究。的 韦恩州立大学的机构环境提供了广泛的 新生儿-围产期司 医疗服务在Hutzel医院和儿童医院都很忙碌。 密歇根职业发展计划包括正式的指导，广泛的 临床研究设计硕士课程， 统计分析，临床和补充实验室的实施 与患者导向研究相关的研究。苏德博士的导师西莎 Shankaran，MD，是一位著名的生物学家，在 涉及多个多中心临床的临床研究设计 通过NICHD新生儿研究网络进行试验。她已经建立 与整个密歇根州的植物学家和 这将有助于Sood博士提出的研究。JV Aranda医学博士、博士 和V Delaney-Black医学博士，公共卫生硕士将担任这项研究的顾问。苏德博士建议 使用雾化前列腺素E1（PGE 1）作为 选择性肺血管扩张剂治疗持续性肺动脉高压 新生儿高血压（PPHN）。这是研究计划的两个阶段。 最初，在足月儿和近足月儿中进行的PGE 1雾化吸入的I期初步研究 与PPHN将在密歇根州儿童医院进行（已经 正在进行中）与底特律地区的其他医院合作， 确定PGE 1的适当剂量。在第二阶段， 前列腺素E_1（PGE_1）雾化吸入治疗前列腺癌的最佳剂量的对照研究 将对这些单位进行评估，以评价疗效。如果有效， 使用雾化PGE 1治疗新生儿PPHN作为一项多中心研究， NICHD新生儿网络。