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Randomized Controlled Trial
. 2017 Jul 21;18(1):343.
doi: 10.1186/s13063-017-2031-3.

Effectiveness and Cost-Effectiveness of Daily All-Over-Body Application of Emollient During the First Year of Life for Preventing Atopic Eczema in High-Risk Children (The BEEP Trial): Protocol for a Randomised Controlled Trial

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Randomized Controlled Trial

Effectiveness and Cost-Effectiveness of Daily All-Over-Body Application of Emollient During the First Year of Life for Preventing Atopic Eczema in High-Risk Children (The BEEP Trial): Protocol for a Randomised Controlled Trial

Joanne R Chalmers et al. Trials. .
Free PMC article


Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis).

Methods: This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires.

Discussion: This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases.

Trial registration: ISRCTN registry; ID: ISRCTN21528841 . Registered on 25 July 2014.

Keywords: Atopic dermatitis; Barrier enhancement; Core outcomes; Eczema; Emollient; Filaggrin; Prevention; Protocol; Randomised controlled trial.


Fig. 1
Fig. 1
Schematic diagram showing the trial design and duration for participating families
Fig. 2
Fig. 2
Flowchart indicating participant flow through the trial
Fig. 3
Fig. 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure showing important events in the trial and their respective time points. EASI - Eczema Area and Severity Index, POEM Patient Oriented Eczema Measure, EQ-5D-5 L – EuroQol Five Dimension, CHU-9D – The Child Health Utility. 1The 24 month is a face-to-face visit from the research nurses blinded to treatment allocation. 2Hayfever status assessed at 60 month only. 3Washing practices only

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    1. Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, et al. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004;113(5):832–6. doi: 10.1016/j.jaci.2003.12.591. - DOI - PubMed
    1. Malik G, Tagiyeva N, Aucott L, McNeill G, Turner SW. Changing trends in asthma in 9-12 year olds between 1964 and 2009. Arch Dis Child. 2011;96(3):227–31. doi: 10.1136/adc.2010.189175. - DOI - PubMed
    1. Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009;124(6):1251–8. e23. doi: 10.1016/j.jaci.2009.10.009. - DOI - PubMed
    1. Williams HC, Wüthrich B. Atopic dermatitis; The epidemiology, causes and prevention of atopic eczema. Cambridge University Press; 2000
    1. Kemp AS. Cost of illness of atopic dermatitis in children: a societal perspective. Pharmacoeconomics. 2003;21(2):105–13. doi: 10.2165/00019053-200321020-00003. - DOI - PubMed

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