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.; Bradshaw, Lucy E.; Montgomery, Alan A.; Boyle, Robert J.; Williams, Hywel C.

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 healthcare 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. 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 have 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, 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 healthcare providers throughout the world by preventing AE and possibly other associated allergic diseases.

Citation

Chalmers, J. R., Haines, R. H., Mitchell, E. J., Thomas, K. S., Brown, S. J., Ridd, M., Lawton, S., Simpson, E. L., Cork, M. J., Sach, T. H., Bradshaw, L. E., Montgomery, A. A., Boyle, R. J., & Williams, H. 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(1), Article 343. https://doi.org/10.1186/s13063-017-2031-3

• Journal Article Type: Article
• Acceptance Date: May 31, 2017
• Online Publication Date: Jul 21, 2017
• Publication Date: Jul 21, 2017
• Deposit Date: Jul 19, 2017
• Publicly Available Date: Jul 21, 2017
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 18
• Issue: 1
• Article Number: 343
• DOI: https://doi.org/10.1186/s13063-017-2031-3
• Keywords: Protocol, randomised controlled trial, eczema, atopic dermatitis, prevention, emollient, barrier enhancement, filaggrin, core outcomes
• Public URL: https://nottingham-repository.worktribe.com/output/873335
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2031-3
• Contract Date: Jul 19, 2017