• Jemma Cleminson and William McGuire.
• University of York, York, UK. Electronic address: cleminsonjemma@gmail.com.
• Lancet. 2015 Feb 26; 385 Suppl 1: S31.

BackgroundBreakdown 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.MethodsWe 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.FindingsWe 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).InterpretationThe 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.FundingNational Institute for Health Research.Copyright © 2015 Elsevier Ltd. All rights reserved.

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