University of York, York, UK.
University of York, York, UK.
Lancet. 2015 Feb 26;385 Suppl 1:S31. doi: 10.1016/S0140-6736(15)60346-4.
Breakdown of the developmentally immature epidermal barrier in the preterm infant can permit entry of microorganisms leading to invasive infection. Topical emollients might improve skin integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in these infants. The aim of this study was to appraise and synthesise the evidence for topical application of emollients in the prevention of invasive infection and mortality in preterm infants.
We conducted a systematic review of randomised controlled trials that assessed the effect of prophylactic application of topical emollient (ointments, creams, or oils) on the incidence of invasive infection, and other morbidity and mortality in preterm infants. We used the standard methods of the Cochrane Neonatal Group to identify and appraise trials and extract and synthesise data. We prespecified subgroup analyses of trials in low-income and middle-income versus high-income countries.
We included 16 trials (2809 infants). Methodological quality varied, with uncertainty about adequate allocation concealment methods in eight trials and lack of masking in all of the trials. Most trials in high-income countries compared expensive proprietary ointments or creams with standard care. Meta-analysis showed a significantly higher incidence of infection in infants treated with emollient (relative risk 1·20, 95% CI 1·01-1·42), but no significant effect on mortality or other morbidity. In low-income or middle-income countries, most trials compared low-cost natural plant oils with standard care, and meta-analyses did not show a significant effect on infection or mortality. Topical oil application increased rates of weight gain (∼2 g/kg per day) and gain in length (∼1 mm/kg per week).
The available trial data do not provide strong evidence that emollients prevent invasive infection or death in preterm infants. Given the burden of infectious morbidity and mortality in preterm infants in low-income or middle-income countries, further large, pragmatic trials of topical oils (which are low-cost, readily available, and widely accepted traditional neonatal skin care practices) are justified to improve the precision of the estimates of effect size.
National Institute for Health Research.
早产儿发育不成熟的表皮屏障破裂会使微生物进入，导致侵袭性感染。局部保湿剂可改善皮肤完整性和屏障功能，从而预防侵袭性感染，这是早产儿死亡率和发病率的主要原因。本研究旨在评估和综合预防性应用保湿剂预防早产儿侵袭性感染和死亡的证据。
我们系统地回顾了评估预防性应用局部保湿剂（软膏、乳膏或油剂）对早产儿侵袭性感染发生率以及其他发病率和死亡率影响的随机对照试验。我们使用 Cochrane 新生儿组的标准方法来识别和评估试验，并提取和综合数据。我们对低收入和中等收入国家与高收入国家的试验进行了亚组分析。
我们纳入了 16 项试验（2809 名婴儿）。方法学质量差异很大，8 项试验的分配隐藏方法不充分，所有试验均未进行盲法。大多数高收入国家的试验比较了昂贵的专利软膏或乳膏与标准护理。荟萃分析显示，使用保湿剂的婴儿感染发生率显著增加（相对风险 1.20，95%CI 1.01-1.42），但对死亡率或其他发病率无显著影响。在低收入或中等收入国家，大多数试验比较了低成本天然植物油与标准护理，荟萃分析未显示对感染或死亡率有显著影响。局部涂油增加了体重增加（每天约 2 克/公斤）和长度增加（每周约 1 毫米/公斤）的速度。
现有的试验数据并未提供强有力的证据表明保湿剂可预防早产儿侵袭性感染或死亡。鉴于低收入或中等收入国家早产儿感染发病率和死亡率的负担，进一步进行大型、实用的局部油剂试验（这种油剂成本低、易于获得且广泛被接受为传统新生儿皮肤护理方法）是合理的，可以提高效应大小估计的准确性。
英国国家卫生研究院。
