CORE--CLINICAL CORE

（改编自申请人摘要）本SCOR的临床核心 将指导管理发病机制的临床研究， 治疗足月儿和早产儿的急性呼吸衰竭。 核心将确定适当的患者进行研究，负责 与行为有关的患者知情同意和管理 的研究。核心将处理收集和分发到 临床样本的基础科学研究者。中央数据收集 沿着专门的生物统计咨询 将提供。 与合作者的安排，以促进和加强临床 研究将是核心的责任。最重要的目标 这一核心是为了促进替补结果的平稳过渡 基础科学研究人员的研究，以研究和/或治疗 在托儿所的试验。核心将与这些调查人员合作， 临床项目的设计，并将与机构 审查委员会，以确保适当的保护婴儿参加 这些研究。 急性呼吸衰竭合并肺动脉高压是一种 是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 降低呼吸道疾病的死亡率。然而，有些婴儿失败了。 对外源性药物的给药反应或反应不佳 表面活性相关的肺动脉高压导致严重程度 这些婴儿的疾病。临床核心的一个重点是 检查早产儿严重呼吸衰竭的假设， 婴儿部分与血管异常和肺 高血压该病症的发病机制将使用 超声心动图和测量血管调节介质， 氧化损伤发病机制的研究将在 安慰剂对照研究的背景下， 特异性肺血管扩张剂吸入一氧化氮核心还将 用新的管理方法在以往成功的基础上扩大 呼吸衰竭患儿的治疗策略。吸入一氧化氮 氧化物已被证明是一个有用的治疗在许多这些婴儿。 然而，一些婴儿对这种疗法反应不佳或仅部分反应。 这些婴儿的核心重点将是了解 不良反应的发病机制和持续治疗的发展 以增强这组婴儿对吸入一氧化氮的反应。 最后，该中心将对所有接受治疗的婴儿进行随访， 早产儿和足月儿呼吸衰竭的治疗试验 婴儿，以评估新疗法的安全性， 神经发育和心肺结果。

(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.