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

Chalmers, Joanne R., Haines, Rachel H., Mitchell, Eleanor J., Thomas, Kim S., Brown, Sara J., Ridd, Matthew, Lawton, Sandra, Simpson, Eric L., Cork, Michael J, Sach, Tracey H. ORCID: https://orcid.org/0000-0002-8098-9220, Bradshaw, Lucy E., Montgomery, Alan A., Boyle, Robert J. and Williams, Hywel C. (2017) 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. Trials, 18. ISSN 1745-6215

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Abstract

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.

Item Type:	Article
Uncontrolled Keywords:	protocol,randomised controlled trial,eczema,atopic dermatitis,prevention,emollient,barrier enhancement
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023) Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Health Economics
Depositing User:	Pure Connector
Date Deposited:	27 Jul 2017 05:05
Last Modified:	22 Oct 2022 02:43
URI:	https://ueaeprints.uea.ac.uk/id/eprint/64278
DOI:	10.1186/s13063-017-2031-3

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