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
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...
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| Format: | Article |
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BioMed Central
2017
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| Online Access: | https://eprints.nottingham.ac.uk/44277/ |
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| author | Chalmers, J.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. |
| author_facet | Chalmers, J.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. |
| author_sort | Chalmers, J.R. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T19:54:59Z |
| format | Article |
| id | nottingham-44277 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:54:59Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-442772020-05-04T18:56:07Z https://eprints.nottingham.ac.uk/44277/ 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, J.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. 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. BioMed Central 2017-07-21 Article PeerReviewed Chalmers, J.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. 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 (343). pp. 1-11. ISSN 1745-6215 Protocol randomised controlled trial eczema atopic dermatitis prevention emollient barrier enhancement filaggrin core outcomes https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2031-3 doi:10.1186/s13063-017-2031-3 doi:10.1186/s13063-017-2031-3 |
| spellingShingle | Protocol randomised controlled trial eczema atopic dermatitis prevention emollient barrier enhancement filaggrin core outcomes Chalmers, J.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. 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Protocol randomised controlled trial eczema atopic dermatitis prevention emollient barrier enhancement filaggrin core outcomes |
| url | https://eprints.nottingham.ac.uk/44277/ https://eprints.nottingham.ac.uk/44277/ https://eprints.nottingham.ac.uk/44277/ |