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, Rachel H. Haines, Eleanor J. Mitchell, Kim S. Thomas, Sara J. Brown, Matthew Ridd, Sandra Lawton, Eric Simpson, Michael J. Cork, Tracey H. Sach, Lucy E. Bradshaw, Alan A. Montgomery, Robert J. Boyle, Hywel C. Williams

Research output: Contribution to journalArticle

17 Citations (Scopus)

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 24months 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 18months with a face-to-face visit at 24months. Long-term follow-up until 60months 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.

Original languageEnglish (US)
Article number343
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Jul 21 2017

Fingerprint

Emollients
Atopic Dermatitis
Clinical Protocols
Cost-Benefit Analysis
Randomized Controlled Trials
Skin Care
Asthma
Food Hypersensitivity
Health Personnel
Quality of Life
Infant Care
Secondary Care
Skin
Seasonal Allergic Rhinitis
Cost Savings
England

Keywords

  • Atopic dermatitis
  • Barrier enhancement
  • Core outcomes
  • Eczema
  • Emollient
  • Filaggrin
  • Prevention
  • Protocol
  • Randomised controlled trial

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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; Cork, Michael J.; Sach, Tracey H.; Bradshaw, Lucy E.; Montgomery, Alan A.; Boyle, Robert J.; Williams, Hywel C.

In: Trials, Vol. 18, No. 1, 343, 21.07.2017.

Research output: Contribution to journalArticle

Chalmers, JR, Haines, RH, Mitchell, EJ, Thomas, KS, Brown, SJ, Ridd, M, Lawton, S, Simpson, E, Cork, MJ, Sach, TH, Bradshaw, LE, Montgomery, AA, Boyle, RJ & Williams, HC 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, vol. 18, no. 1, 343. https://doi.org/10.1186/s13063-017-2031-3
Chalmers, Joanne R. ; Haines, Rachel H. ; Mitchell, Eleanor J. ; Thomas, Kim S. ; Brown, Sara J. ; Ridd, Matthew ; Lawton, Sandra ; Simpson, Eric ; 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. In: Trials. 2017 ; Vol. 18, No. 1.
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AU - Chalmers, Joanne R.

AU - Haines, Rachel H.

AU - Mitchell, Eleanor J.

AU - Thomas, Kim S.

AU - Brown, Sara J.

AU - Ridd, Matthew

AU - Lawton, Sandra

AU - Simpson, Eric

AU - Cork, Michael J.

AU - Sach, Tracey H.

AU - Bradshaw, Lucy E.

AU - Montgomery, Alan A.

AU - Boyle, Robert J.

AU - Williams, Hywel C.

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N2 - 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 24months 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 18months with a face-to-face visit at 24months. Long-term follow-up until 60months 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.

AB - 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 24months 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 18months with a face-to-face visit at 24months. Long-term follow-up until 60months 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.

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KW - Prevention

KW - Protocol

KW - Randomised controlled trial

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