CORE--CLINICAL CORE

核心--临床核心

• 批准号: 6410583
• 负责人: ADAM A ROSENBERG
• 金额: $ 20.88万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-15 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6410583
• 关键词: atrial natriuretic peptide; biomedical facility; clinical research; human subject; human therapy evaluation; inhalation drug administration; longitudinal human study; newborn human (0-6 weeks); nitric oxide; oxidative stress; pathologic process; premature infant human; pulmonary hypertension; pulmonary surfactants; respiratory distress syndrome of newborn; respiratory insufficiency /failure; vasodilation

(Adapted from the applicant's abstract) The clinical core of this SCOR will direct the management of clinical studies of the pathogenesis and treatment of acute respiratory failure in the term and pre-term infant. The core will identify appropriate patients for study, be responsible for informed consent and management of the patient as pertains to the conduct of the study. The core will handle collection of and distribution to the basic science investigators of clinical samples. Central data collection and analysis facilities along with dedicated biostatistical consultation will be provided. Arrangements with collaborators to facilitate and augment the clinical studies will be the responsibility of the core. The most important goal of this core is to facilitate the smooth transition of results of bench research of the basic science investigators to studies and/or therapeutic trials in the nursery. The core will collaborate on these investigators on the design of clinical projects and will work with the Institutional Review board to assure proper protection for the infants participating in these studies. Acute respiratory failure with associated pulmonary hypertension is a major cause of morbidity and mortality in both term and pre-term infants. In the pre-term infant, the use of surfactant replacement therapy has decreased mortality from respiratory disease. However, some infants fail to respond or respond poorly to the administration of exogenous surfactant. Associated pulmonary hypertension contributes to the severity of illness in these infants. One focus of the clinical core will be to examine the hypothesis that severe respiratory failure in the pre-mature infant is in part related to vascular abnormalities and pulmonary hypertension. The pathogenesis of the condition will be studies using echocardiography and measurement of mediators of vascular regulation and oxidant injury. The study of pathogenesis will take place within the context of a placebo controlled study of the safety and efficacy of the specific pulmonary vasodilator, inhaled nitric oxide. The core will also expand upon previous success upon previous success with new management strategies in the term infant with respiratory failure. Inhaled nitric oxide has been shown to be a useful therapy in many of these infants. However, some infants respond poorly or only partially to this therapy. The focus of the core in these infants will be to understand the pathogenesis of a poor response and the development of adjunctive therapy to augment the response to inhaled nitric oxide in this group of infants. Finally, the core will run a follow up program for all infants treated in therapeutic trials treating respiratory failure in pre-term and term infants to assess the safety of the new therapies in the context of neurodevelopmental and cardiopulmonary outcomes.

（改编自申请人的摘要）此SCOR的临床核心 将指导发病机理临床研究和 治疗急性呼吸衰竭期限和术前婴儿。 核心将确定适合研究的患者，负责 患者的知情同意和管理与行为有关 研究。核心将处理和分配到 临床样本的基础科学研究者。中央数据收集 和分析设施以及专门的生物统计学咨询 将提供。 与合作者的安排，以促进和增加临床 研究将是核心的责任。最重要的目标 该核心是为了促进板凳结果的平稳过渡 研究和/或治疗的基础科学研究者的研究 托儿所的试验。核心将与这些调查人员合作 临床项目的设计，并将与机构合作 审核委员会确保对参加的婴儿进行适当的保护 这些研究。 急性呼吸衰竭与相关肺动脉高压是 术语和前婴儿发病和死亡率的主要原因。 在早期婴儿中，表面活性剂替代疗法的使用已有 呼吸道疾病的死亡率降低。但是，有些婴儿失败了 对外源的响应或反应不佳 表面活性剂。相关的肺动脉高压有助于严重性 这些婴儿的疾病。临床核心的一个重点是 检查以下假设 婴儿部分与血管异常和肺部有关 高血压。病情的发病机理将是使用 超声心动图和血管调节介体的测量 氧化剂损伤。发病机理的研究将在 安慰剂对照研究的背景 特异性肺血管扩张剂，吸入一氧化氮。核心也将 扩大以前成功的成功，并在新管理方面取得成功 婴儿术语中的策略呼吸衰竭。吸入一硝 在许多此类婴儿中，氧化物已被证明是一种有用的疗法。 但是，一些婴儿对这种疗法的反应不佳或部分反应。 这些婴儿中核心的重点是了解 反应不佳的发病机理和辅助治疗的发展 增加对这组婴儿中吸入一氧化氮的反应。 最后，核心将针对所有接受治疗的婴儿进行后续计划 治疗前和期治疗呼吸衰竭的治疗试验 婴儿在评估新疗法的安全性 神经发育和心肺结局。