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Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial.

Chalmers, JR; Haines, RH; Bradshaw, LE; Montgomery, AA; Thomas, KS; Brown, SJ; Ridd, MJ; Lawton, S; Simpson, EL; Cork, MJ; et al. Chalmers, JR; Haines, RH; Bradshaw, LE; Montgomery, AA; Thomas, KS; Brown, SJ; Ridd, MJ; Lawton, S; Simpson, EL; Cork, MJ; Sach, TH; Flohr, C; Mitchell, EJ; Swinden, R; Tarr, S; Davies-Jones, S; Jay, N; Kelleher, MM; Perkin, MR; Boyle, RJ; Williams, HC; BEEP study team (2020) Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet, 395 (10228). pp. 962-972. ISSN 1474-547X
SGUL Authors: Perkin, Michael Richard

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BACKGROUND: Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children. METHODS: We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment. FINDINGS: 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09). INTERPRETATION: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn. FUNDING: National Institute for Health Research Health Technology Assessment.

Item Type: Article
Additional Information: Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
Keywords: BEEP study team, General & Internal Medicine, 11 Medical and Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Lancet
ISSN: 1474-547X
Language: eng
21 March 2020Published
19 February 2020Published Online
21 November 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Project IDFunderFunder ID
12/67/12National Institute for Health Research
CA15008Sheffield Children's Hospital Research FundUNSPECIFIED
106865/Z/15/ZWellcome Trust
CDF-2014–07–037National Institute for Health Research
TRF-2017–10–003National Institute for Health Research
PDF-2014–07–013National Institute for Health Research
PubMed ID: 32087126
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