Bradshaw, LE;
Wyatt, LA;
Brown, SJ;
Haines, RH;
Montgomery, AA;
Perkin, MR;
Sach, TH;
Lawton, S;
Flohr, C;
Ridd, MJ;
et al.
Bradshaw, LE; Wyatt, LA; Brown, SJ; Haines, RH; Montgomery, AA; Perkin, MR; Sach, TH; Lawton, S; Flohr, C; Ridd, MJ; Chalmers, JR; Brooks, J; Swinden, R; Mitchell, EJ; Tarr, S; Jay, N; Thomas, KS; Allen, H; Cork, MJ; Kelleher, MM; Simpson, EL; Lartey, ST; Davies-Jones, S; Boyle, RJ; Williams, HC
(2024)
Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.
Health Technol Assess, 28 (29).
pp. 1-116.
ISSN 2046-4924
https://doi.org/10.3310/RHDN9613
SGUL Authors: Perkin, Michael Richard
Abstract
BACKGROUND: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life. OBJECTIVES: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children. DESIGN: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years. SETTING: Twelve secondary and four primary care centres. PARTICIPANTS: Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery. INTERVENTIONS: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation. MAIN OUTCOME MEASURES: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness. RESULTS: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires. LIMITATIONS: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes. CONCLUSIONS: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context. FUTURE RESEARCH: To pool similar studies in an individual patient data meta-analysis. TRIAL REGISTRATION: This trial is registered as ISRCTN21528841. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.
Item Type: |
Article
|
Additional Information: |
Copyright © 2024 Bradshaw et al. This work was produced by Bradshaw et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. |
Keywords: |
ASTHMA, ATOPIC DERMATITIS, ATOPIC ECZEMA, ECZEMA, EMOLLIENTS, FILAGGRIN, FOOD ALLERGY, HAY FEVER, INFLAMMATION, MOISTURISERS, PREVENTION, RANDOMISED CONTROLLED TRIAL, SKIN BARRIER, SKIN SENSITISATION, Humans, Emollients, Female, Male, Infant, Infant, Newborn, Eczema, Cost-Benefit Analysis, United Kingdom, Child, Preschool, Quality-Adjusted Life Years, Quality of Life, Technology Assessment, Biomedical, Dermatitis, Atopic, Humans, Dermatitis, Atopic, Eczema, Emollients, Quality-Adjusted Life Years, Quality of Life, Child, Preschool, Infant, Infant, Newborn, Cost-Benefit Analysis, Technology Assessment, Biomedical, Female, Male, United Kingdom, 0806 Information Systems, 0807 Library and Information Studies, 1117 Public Health and Health Services, Health Policy & Services |
SGUL Research Institute / Research Centre: |
Academic Structure > Population Health Research Institute (INPH) Academic Structure > REF 2021 user group |
Journal or Publication Title: |
Health Technol Assess |
ISSN: |
2046-4924 |
Language: |
eng |
Dates: |
Date | Event |
---|
1 July 2024 | Published | 1 May 2023 | Accepted |
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Publisher License: |
Creative Commons: Attribution 4.0 |
Projects: |
|
PubMed ID: |
39021147 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/116723 |
Publisher's version: |
https://doi.org/10.3310/RHDN9613 |
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