Shinwell Eric S, Portnov Igor, Meerpohl Joerg, Karen Tanja, Bassler Dirk
Department of Neonatology, Ziv Medical Center, Rambam Street, Tsfat, 13100, Israel.
Cochrane Germany, Medical Center, University of Freiburg, Berliner Allee 29, 79110, Freiburg, Germany.
Syst Rev. 2015 Sep 25;4:127. doi: 10.1186/s13643-015-0108-1.
Inhaled steroids have been studied for both prevention and treatment of bronchopulmonary dysplasia (BPD). Results have been inconsistent. Recently, a large randomized controlled trial (RCT) has been reported.
METHODS/DESIGN: We will perform a comprehensive systematic literature search for randomized and quasi-randomized controlled trials that studied the efficacy and safety of inhaled corticosteroids administered to preterm infants (22-36 weeks) for either the prevention or treatment of BPD diagnosed by both clinical and physiological outcome criteria. We will assess potential risk of bias for each RCT meeting our selection criteria using the Cochrane risk of bias tool for RCTs. The primary outcome of interest will be mortality or BPD or both at 28 days postnatal age or 36 weeks postmenstrual age. Pooled estimates will be calculated using RevMan software with a random effects model as primary analysis. We will assess the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Meta-analytic estimates of eligible RCTs, potentially including a new large RCT, may significantly influence neonatal practice in the prevention and treatment of respiratory problems in preterm infants.
PROSPERO CRD42015019628.
吸入性类固醇已被用于支气管肺发育不良（BPD）的预防和治疗研究。结果并不一致。最近，一项大型随机对照试验（RCT）已被报道。
方法/设计：我们将对随机和半随机对照试验进行全面的系统文献检索，这些试验研究了吸入性皮质类固醇用于预防或治疗通过临床和生理结果标准诊断为BPD的早产儿（22 - 36周）的疗效和安全性。我们将使用Cochrane随机对照试验偏倚风险工具评估每个符合我们选择标准的随机对照试验的潜在偏倚风险。感兴趣的主要结局将是出生后28天或月经龄36周时的死亡率或BPD或两者。将使用RevMan软件以随机效应模型作为主要分析方法计算合并估计值。我们将使用推荐分级评估、制定和评价（GRADE）方法评估证据质量。
符合条件的随机对照试验的荟萃分析估计，可能包括一项新的大型随机对照试验，可能会显著影响早产儿呼吸问题预防和治疗中的新生儿实践。
PROSPERO CRD42015019628
