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)本SCOR的临床核心 将指导对发病机制和临床研究的管理 足月和早产儿急性呼吸衰竭的治疗。 核心将确定合适的患者进行研究，负责 与行为有关的患者的知情同意和管理 这项研究的结果。核心将处理收集和分发到 临床标本的基础科学研究人员。中央数据收集 和分析设施，以及专门的生物统计咨询 将会被提供。 与合作者的安排，以促进和加强临床 学习将是核心的责任。最重要的目标是 这一核心是为了促进BASE结果的平稳过渡 基础科学研究人员的研究和/或治疗 在托儿所里进行试验。核心将就这些调查人员进行合作 临床项目的设计，并将与机构合作 审核委员会确保为参与该计划的婴儿提供适当保护 这些研究。 急性呼吸衰竭合并肺动脉高压是一种 足月儿和早产儿发病和死亡的主要原因。 在早产儿中，表面活性物质替代疗法的使用 降低呼吸系统疾病的死亡率。然而，一些婴儿失败了 对外源药物的使用反应或反应不佳 表面活性剂。伴发的肺动脉高压导致严重程度 这些婴儿患病的可能性。临床核心的一个重点将是 检验早产儿严重呼吸衰竭的假设 婴幼儿部分与血管异常和肺 高血压。这种情况的发病机制将使用以下方法进行研究 超声心动图与血管调节和血管活性物质的测定 氧化损伤。对发病机制的研究将在 安慰剂对照研究的安全性和有效性 特定的肺血管扩张剂，吸入一氧化氮。核心也将 利用新的管理层在以前成功的基础上扩展以前的成功 新生儿呼吸衰竭的治疗策略。吸入亚硝酸盐 氧化物已被证明对其中许多婴儿是一种有用的治疗方法。 然而，一些婴儿对这种疗法的反应很差或只有部分反应。 这些婴儿的核心将是理解 不良反应的发病机制及辅助治疗的进展 以增强这组婴儿对吸入一氧化氮的反应。 最后，该中心将为所有接受治疗的婴儿运行后续计划 治疗早产儿和足月儿呼吸衰竭的治疗试验 在以下情况下评估新疗法的安全性 神经发育和心肺结果。