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用于已确诊支气管肺发育不良的类固醇使用:系统评价和荟萃分析的研究方案。

Steroid use for established bronchopulmonary dysplasia: study protocol for a systematic review and meta-analysis.

机构信息

University of Limerick Graduate Entry Medical School, Limerick, Ireland.

Neonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, Poland

出版信息

BMJ Open. 2022 Jun 15;12(6):e059553. doi: 10.1136/bmjopen-2021-059553.

Abstract

INTRODUCTION

Postnatal steroids during the first few weeks of life have been demonstrated to be effective in decreasing the incidence of bronchopulmonary dysplasia (BPD), a serious chronic respiratory condition affecting preterm infants. However, this preventive option is limited by the concern of neurological side effects. Steroids are used to treat established BPD in an attempt to reduce mortality, and length of stay and home oxygen therapy, both of which associated with high levels of parental stress and healthcare costs. Moreover, a late timing for steroid treatment may show a more favourable safety profile in terms of neurodevelopment outcomes, considering the added postnatal brain maturation of these infants. Here, we report a protocol for a systematic review, which aims to determine the efficacy and long-term safety of postnatal steroids for the treatment of established BPD in preterm infants.

METHODS AND ANALYSIS

MEDLINE, Embase, Cochrane databases and sources of grey literature for conference abstracts and trial registrations will be searched with no time or language restriction. We will include case-control studies, cohort studies and non-randomised or randomised trials that evaluate postnatal steroids for infants diagnosed with moderate or severe established BPD at 36 weeks' postmenstrual age. We will pool data from studies that are sufficiently similar to make this appropriate. Data extraction forms will be developed a priori. Observational studies and non-randomised and randomised clinical trials will be analysed separately. We will combine OR with 95% CI for dichotomous outcomes and the mean difference (95% CI) for continuous outcomes. We will account for the expected heterogeneity by using a random-effects model. We will perform subgroup analysis based on the a priori determined covariate of interest.

ETHICS AND DISSEMINATION

Systematic reviews are exempted from approval by an ethics committee. Attempts will be sought to publish all results.

PROSPERO REGISTRATION NUMBER

CRD42021218881.

摘要

简介

在生命的最初几周内给予产后类固醇已被证明可有效降低支气管肺发育不良(BPD)的发生率,BPD 是一种影响早产儿的严重慢性呼吸系统疾病。然而,这种预防选择受到神经副作用的担忧的限制。类固醇用于治疗已确立的 BPD,试图降低死亡率和住院时间以及家庭氧疗,这些都与高水平的父母压力和医疗保健费用相关。此外,考虑到这些婴儿的额外的产后大脑成熟,晚期给予类固醇治疗在神经发育结果方面可能具有更有利的安全性。在这里,我们报告了一项系统评价的方案,旨在确定产后类固醇治疗早产儿已确立的 BPD 的疗效和长期安全性。

方法和分析

将对 MEDLINE、Embase、Cochrane 数据库以及灰色文献来源(会议摘要和试验登记册)进行无时间或语言限制的搜索。我们将包括病例对照研究、队列研究和非随机或随机试验,这些研究评估了在 36 周胎龄后诊断为中度或重度已确立的 BPD 的婴儿使用产后类固醇的情况。我们将从足够相似的研究中汇总数据。将预先制定数据提取表。将分别分析观察性研究、非随机和随机临床试验。我们将使用随机效应模型来解释预期的异质性。我们将根据事先确定的感兴趣的协变量进行亚组分析。

伦理和传播

系统评价豁免伦理委员会的批准。将努力发表所有结果。

PROSPERO 注册号:CRD42021218881。

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