INHALED BECLOMETHASONE TO PREVENT CHRONIC LUNG DISEASE

吸入倍氯米松预防慢性肺病

• 批准号: 2225846
• 负责人: IVAN D FRANTZ
• 金额: $ 73.25万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-06-01 至 1998-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2225846
• 关键词: bronchopulmonary dysplasia; cell differentiation; clinical trials; dosage; drug adverse effect; glucocorticoids; growth /development; human subject; human therapy evaluation; inflammation; medical complication; patient care management; postnatal growth disorder; premature infant human; radiography; respiratory disorder chemotherapy; respiratory distress syndrome of newborn; respiratory function; respiratory therapy

We hypothesize that administration of an inhaled glucocorticoid early in the course of respiratory failure in premature infants will reduce the occurrence of chronic lung disease with few systemic side effects. We hypothesize further that prevention of chronic lung disease, often known as bronchopulmonary dysplasia, in the neonatal period will result in improved pulmonary function and neurodevelopmental status when infants are followed until 18 months of age. These hypotheses will be tested through a multicenter, randomized, double blind, placebo controlled clinical trial. Premature delivery accompanied by elevated inspired oxygen concentration and positive pressure ventilation disrupts the normal process of growth add differentiation of the lung. This disruption is mediated by inflammation, cellular damage and abnormal repair, processes which are mediated through local production and action of cytokines. In this project we will determine whether this process can be inhibited by an inhaled glucocorticoid, beclomethasone, allowing normal growth and differentiation to occur. By starting inhaled steroids as early as 5 days of age we hope to prevent rather than treat chronic lung disease. Direct administration of the drug to its site of action should disrupt local processes of inflammation and damage allowing for lower doses and thus avoiding the complications of high dose systemic steroids. The multicenter approach, involving a large number of patients of diverse background and subtle differences in management, will allow the results to be generalized to the population of infants with respiratory failure as a whole. The major endpoint will be the need for supplemental oxygen and a chest radiograph consistent with chronic bronchopulmonary dysplasia at 28 days of life. The occurrence of these findings at 36 weeks post- conception will also be recorded. Side effects to be compared include growth failure, hypothalamic-pituitary-adrenal axis suppression, hyperglycemia, hypertension and infection. Chronic effects on pulmonary status, growth and neurodevelopment will be determined through follow-up to age 18 months. The trial will be conducted at two Tufts University School of Medicine Neonatal Intensive Care Units, located at New England Medical Center and Baystate Medical Center. The Data Coordinating Center and statistical analysis will be at the Department of Epidemiology and Biostatistics at the Boston University School of Public Health.

我们假设早期吸入糖皮质激素 在早产儿呼吸衰竭的过程中， 慢性肺部疾病的发生，全身副作用少。 我们进一步假设，预防慢性肺病，通常 称为支气管肺发育不良，在新生儿期将导致 改善肺功能和神经发育状态， 对婴儿进行跟踪直至18个月。 这些假设将是 通过多中心、随机、双盲、安慰剂试验 对照临床试验。 早产伴高血压 吸入氧浓度和正压通气 破坏了肺的正常生长和分化过程。 这种破坏是由炎症、细胞损伤和 异常修复，通过当地生产介导的过程 和细胞因子的作用。 在这个项目中，我们将确定是否 该过程可以通过吸入糖皮质激素来抑制， 倍氯米松，允许正常生长和分化发生。 通过在婴儿出生后5天开始吸入类固醇，我们希望 预防而不是治疗慢性肺病。 直辖 药物的作用部位应该破坏局部的过程， 炎症和损伤允许较低的剂量，从而避免 高剂量全身性类固醇的并发症。多中心方法， 涉及大量不同背景和微妙的患者 管理的差异，将使结果被推广到 婴儿呼吸衰竭的总体情况。 的 主要终点是需要补充氧气和胸腔 28岁时的X线片与慢性支气管肺发育不良一致 天的生命。 这些发现在术后36周发生， 怀孕也将被记录。 要比较的副作用包括 生长障碍，下丘脑-垂体-肾上腺轴抑制， 高血糖、高血压和感染。 慢性影响 将确定肺状态、生长和神经发育 随访至18个月。审判将在两点进行 塔夫茨大学医学院新生儿重症监护室， 位于新英格兰医疗中心和Baystate医疗中心。 的 数据协调中心和统计分析将在 波士顿大学流行病学和生物统计学系 公共卫生学院。