Gordon Adrienne, Greenhalgh Mark, McGuire William
Neonatology, Royal Prince Alfred Hospital, Missenden Road, Camperdown, Sydney, NSW, Australia, 2050.
Cochrane Database Syst Rev. 2017 Oct 10;10(10):CD012142. doi: 10.1002/14651858.CD012142.pub2.
Lengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous catheters (UVCs) is recommended to reduce the incidence of infection and associated morbidity and mortality.
To compare the effectiveness of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.To perform subgroup analyses by gestational age at birth and prespecified planned duration of UVC placement (see "Subgroup analysis and investigation of heterogeneity").
We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4), Ovid MEDLINE, Embase, and the Maternity & Infant Care Database (until May 2017), as well as conference proceedings and previous reviews.
Randomised and quasi-randomised controlled trials that compared effects of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.
Two review authors assessed trial eligibility and risk of bias and independently undertook data extraction. We analysed treatment effects and reported risk ratio (RR) and risk difference (RD) for dichotomous data, and mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We planned to use a fixed-effect model in meta-analyses and to explore potential causes of heterogeneity in sensitivity analyses. We assessed the quality of evidence for the main comparison at the outcome level using GRADE methods.
We found one eligible trial. Participants were 210 newborn infants with birth weight less than 1251 grams. The trial was unblinded but otherwise of good methodological quality. This trial compared removal of an umbilical venous catheter within 10 days after insertion (and replacement with a peripheral cannula or a percutaneously inserted central catheter as required) versus expectant management (UVC in place up to 28 days). More infants in the early planned removal group than in the expectant management group (83 vs 33) required percutaneous insertion of a central catheter (PICC). Trial results showed no difference in the incidence of catheter-related bloodstream infection (RR 0.65, 95% CI 0.35 to 1.22), in hospital mortality (RR 1.12, 95% CI 0.42 to 2.98), in catheter-associated thrombus necessitating removal (RR 0.33, 95% confidence interval 0.01 to 7.94), or in other morbidity. GRADE assessment indicated that the quality of evidence was "low" at outcome level principally as the result of imprecision and risk of surveillance bias due to lack of blinding in the included trial.
AUTHORS' CONCLUSIONS: Currently available trial data are insufficient to show whether early planned removal of umbilical venous catheters reduces risk of infection, mortality, or other morbidity in newborn infants. A large, simple, and pragmatic randomised controlled trial is needed to resolve this ongoing uncertainty.
长时间使用可能是新生儿脐静脉导管相关血流感染的一个危险因素。建议早期计划性拔除脐静脉导管(UVC)以降低感染发生率及相关的发病率和死亡率。
比较早期计划性拔除UVC(插入后两周内)与期待疗法或更长固定使用时间在预防新生儿血流感染及其他并发症方面的效果。按出生时的胎龄和预先设定的UVC放置计划时长进行亚组分析(见“亚组分析和异质性研究”)。
我们采用了Cochrane新生儿标准检索策略,包括对Cochrane对照试验中心注册库(CENTRAL;2017年第4期)、Ovid MEDLINE、Embase和母婴护理数据库(截至2017年5月)进行电子检索,以及会议论文集和既往综述。
随机和半随机对照试验,比较早期计划性拔除UVC(插入后两周内)与期待疗法或更长固定使用时间在预防新生儿血流感染及其他并发症方面的效果。
两位综述作者评估试验的合格性和偏倚风险,并独立进行数据提取。我们分析了治疗效果,对于二分数据报告风险比(RR)和风险差(RD),对于连续数据报告均值差(MD),并给出各自的95%置信区间(CI)。我们计划在Meta分析中使用固定效应模型,并在敏感性分析中探索异质性的潜在原因。我们使用GRADE方法在结局层面评估主要比较的证据质量。
我们找到一项合格试验。参与者为210名出生体重小于1251克的新生儿。该试验未设盲,但方法学质量良好。此试验比较了插入后10天内拔除脐静脉导管(并根据需要用外周套管或经皮插入中心导管替换)与期待性处理(UVC留置长达28天)。早期计划性拔除组比期待性处理组更多婴儿(83例对33例)需要经皮插入中心导管(PICC)。试验结果显示,导管相关血流感染发生率(RR 0.65,95%CI 0.35至1.22)、住院死亡率(RR 1.12,95%CI 0.42至2.98)、因导管相关血栓需拔除导管的发生率(RR 0.33,95%置信区间0.01至7.94)或其他发病率方面无差异。GRADE评估表明,结局层面的证据质量为“低”,主要原因是纳入试验缺乏设盲导致的不精确性和监测偏倚风险。
目前可得的试验数据不足以表明早期计划性拔除脐静脉导管是否能降低新生儿感染、死亡或其他发病风险。需要开展一项大型、简单且实用的随机对照试验来解决这一持续存在的不确定性。