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标是：1)评估和比较在出生后前5天开始吸入倍氯米松或安慰剂14天疗程后，30天拔管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记物的影响，包括气管、支气管流出物细胞学以及弹力酶、白细胞介素8和白蛋白的浓度。27名患者参加了这项研究，但在确定足够数量的患者(约66名)之前，分析不会开始。样本量的计算是基于出生后30天拔管患者比例中35%的最小可检测差异。该项目的一个重要部分是确定长期成果衡量标准。要分析的结果包括脑室出血、坏死性小肠结肠炎、早产儿视网膜病变和医院感染。

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.