EFFICACY OF INHALED BECLOMETHASONE IN PREVENTING BRONCHOPULMONARY DYSPLASIA

支气管肺发育不良（BPD），最常见的慢性婴儿 肺疾病，代表了一个重要的国际人道主义和 经济医疗问题。 大约百分之一的婴儿 早产儿发生呼吸窘迫综合征（RDS）， 大约20 - 30%的人会发展成慢性肺疾病 疾病名称BPD。 每年照顾这些婴儿的费用接近 美国每年30亿美元。 虽然行政 外源性肺表面活性剂无疑降低了死亡率 对于早产儿来说，它可能也增加了 通过提高这一高危人群的生存率来治疗BPD。 校长 研究人员的实验室先前已经证明， BPD的急性病理生理学涉及肺部炎症 至少部分由一些强氧自由基介导的反应 发电系统 肺部炎症的程度 早在生命2 - 4天内量化的反应就可以预测这些 患BPD风险最高的婴儿。 这些逻辑的延伸 观察将利用抗炎剂滴定 炎症反应，从而调节相关的炎症反应， 宿主自身损伤 以前的研究已经证明了效用 产前类固醇降低RDS的发生率和严重程度， 和出生后类固醇，在出生后2 - 6周给予， 帮助婴儿脱离机械通气。 几 研究表明，一些肺部 伴随静脉内给药的炎性标志物 与肺功能临床改善相关的类固醇。 两项研究检查了类固醇的给药， 出生-这种策略导致了发病率的下降， BPD的严重性。 几乎所有这些调查都使用了 以逐渐减少的剂量方案静脉注射地塞米松。 尽管一些 副作用已经注意到，在大多数情况下， 短暂的，没有临床问题。 的主要假设 这项研究表明，吸入类固醇开始在出生时， 在治疗的前12天， 生活，降低BPD的发生率，如在36周校正时评估的 孕龄，这种临床效果是反映了一个 减少急性呼吸道感染的肺部炎症反应特征 波士顿警局 还将检查与类固醇相关的次要终点 安慰剂组包括机械通气和吸氧的天数， 新生儿重症监护室（NICU）总天数，NICU护理总费用 和生命第一年慢性肺病的费用。

Bronchopulmonary dysplasia (BPD), the most common form of chronic infant lung disease, represents a significant international humanistic and economic medical problem. Of the approximate one percent of infants born prematurely who develop respiratory distress syndrome (RDS), roughly 20-30 percent will go on to develop a chronic form of lung disease termed BPD. Annual cost for care of such infants approaches $3.0 billion annually in the United States. Although administration of exogenous pulmonary surfactant has unquestionably decreased mortality of very premature infants, it has probably also increased the incidence of BPD by improving survival in this high risk group. The principal investigator's laboratory has previously demonstrated that a key aspect of the acute pathophysiology of BPD involves a pulmonary inflammatory response mediated, at least in part, by a number of potent oxyradical generating systems. The magnitude of this pulmonary inflammatory response quantified as early as 2-4 days of life can predict those infants at highest risk of developing BPD. A logical extension of these observations would utilize anti-inflammatory agents to titrate the inflammatory response and, hence modulate the associated inflammatory host autoinjury. Previous investigations have demonstrated the utility of prenatal steroids in decreasing the incidence and severity of RDS, and of postnatal steroids, administered 2-6 weeks following birth, as an aide to weaning infants from mechanical ventilation. A few investigations have demonstrated a reduction of some pulmonary inflammatory markers concomitant with the administration of intravenous steroids in association with clinical improvement in pulmonary function. Two investigations examined administration of steroids beginning at birth -- this tactic resulted in a decrease in both the incidence and severity of BPD. Nearly all of these investigations have employed intravenous dexamethasone in a tapering dose regimen. Although some side-effects have been noted, for the most part these have been transient and not clinically problematic. The primary hypothesis of this investigation is that inhaled steroids beginning at birth and extended with a tapering dose schedule over the first twelve days of life, decrease the incidence of BPD as assessed at 36 weeks corrected gestational age, and that this clinical effect is mirrored by a reduction in the pulmonary inflammatory response characteristic of acute BPD. Secondary endpoints that will also be examined relative to steroid and placebo groups include days on mechanical ventilation and oxygen, total Neonatal Intensive Care Unit (NICU) days, total NICU care costs and cost of chronic lung disease during the first year of life.