EARLY ADMINISTRATION OF BECLOMETHASONE IN PREMATURE NEONATES AT RISK FOR BPD

这项随机、双盲、安慰剂对照研究的具体目的是：1)评估和比较在出生后5天内开始吸入倍氯米松或安慰剂14天疗程后第30天拔管的婴儿的机械通气总持续时间；2)测量吸入倍氯米松对肺部炎症标志物的影响，包括气管支气管流出细胞细胞学，以及弹性蛋白酶、白细胞介素-8和白蛋白的浓度。27例患者已被纳入本研究，但在确定足够数量的患者（约66例）之前，分析将不会开始。样本量的计算是基于在出生后第30天拔管的患者比例的最小可检测差异35%。该项目的一个重要部分是确定长期结果衡量标准。结果分析包括脑室内出血、坏死性小肠结肠炎、早产儿视网膜病变和医院感染的发展。

The specific aims of this randomized, double-blinded, placebo-controlled study are: 1) evaluate and compare the total duration of mechanical ventilation in the proportion of infants extubated on day 30, following a 14-day course of inhaled beclomethasone or placebo initiated within the first five days of life and; 2) measure the effect of inhaled beclomethasone on markers of pulmonary inflammation, including tracheobronchial effluent cell cytology, and concentrations of elastase, Interleukin-8, and albumin. Twenty-seven patients have been enrolled on this study, but analysis will not begin until a sufficient number of patients (approximately 66) have been ascertained. The sample size calculation was based on a 35% minimal detectable difference in the proportion of patients extubated by post-natal day 30. An important part of this project is to determine long-term outcome measures. Outcomes to be analyzed include development of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, and nosocomial infections.