32
IRUS Total
Downloads
  Altmetric

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

File Description SizeFormat 
1-s2.0-S0140673619329848-main.pdfPublished version507.49 kBAdobe PDFView/Open
Title: Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial
Authors: 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
Item Type: Journal Article
Abstract: 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.
Issue Date: 21-Mar-2020
Date of Acceptance: 1-Feb-2020
URI: http://hdl.handle.net/10044/1/79300
DOI: 10.1016/S0140-6736(19)32984-8
ISSN: 0140-6736
Publisher: Elsevier
Start Page: 962
End Page: 972
Journal / Book Title: The Lancet
Volume: 395
Issue: 10228
Copyright Statement: © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
Sponsor/Funder: National Institutes of Health
Funder's Grant Number: NIHR
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
TRANSEPIDERMAL WATER-LOSS
ATOPIC-DERMATITIS
SKIN BARRIER
MUTATIONS
SEVERITY
PREVALENCE
EXPOSURE
CHILDREN
DISEASE
Dermatitis, Atopic
Dose-Response Relationship, Drug
Drug Administration Schedule
Eczema
Emollients
Female
Follow-Up Studies
Humans
Infant
Infant, Newborn
Male
Reference Values
Risk Assessment
Treatment Outcome
United Kingdom
BEEP study team
Humans
Dermatitis, Atopic
Eczema
Emollients
Treatment Outcome
Drug Administration Schedule
Risk Assessment
Follow-Up Studies
Dose-Response Relationship, Drug
Reference Values
Infant
Infant, Newborn
Female
Male
United Kingdom
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
TRANSEPIDERMAL WATER-LOSS
ATOPIC-DERMATITIS
SKIN BARRIER
MUTATIONS
SEVERITY
PREVALENCE
EXPOSURE
CHILDREN
DISEASE
General & Internal Medicine
11 Medical and Health Sciences
Publication Status: Published
Online Publication Date: 2020-02-19
Appears in Collections:National Heart and Lung Institute