INHALED BECLOMETHASONE TO PREVENT CHRONIC LUNG DISEASE

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会减少 慢性肺部疾病的发生，几乎没有全身副作用。 我们进一步假设，慢性肺部疾病的预防，通常 称为支气管肺发育不良，在新生儿期就会出现 在改善肺功能和神经发育状态时 婴儿一直被跟踪到18个月大。这些假设将是 通过多中心、随机、双盲、安慰剂测试 对照临床试验。早产伴高位 吸入氧气浓度与正压通风 扰乱正常的生长过程，增加肺部的分化。 这种破坏是由炎症、细胞损伤和 不正常的维修，通过当地生产进行调解的过程 以及细胞因子的作用。在这个项目中，我们将确定 吸入糖皮质激素可以抑制这一过程， 倍氯米松，使正常生长和分化发生。 通过在5天大的时候就开始吸入类固醇，我们希望 预防而不是治疗慢性肺病。直接管理 将药物转移到其作用部位应扰乱当地的 炎症和损害，允许较低的剂量，从而避免 大剂量全身类固醇的并发症。多中心方法， 涉及大量不同背景和微妙的患者 管理上的差异，将允许将结果推广到 作为一个整体，呼吸衰竭婴儿的数量。这个 主要终点将是需要补充氧气和胸腔 28岁时与慢性支气管肺发育不良相一致的X线片 生命的日子。这些发现发生在36周后- 受孕也将被记录下来。需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 将确定肺状况、生长和神经发育情况 通过随访至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病房， 位于新英格兰医疗中心和贝斯托医疗中心。这个 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。

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.