| Autor: |
Chalmers, JR, Haines, RH, Bradshaw, LE, Montgomery, AA, Thomas, KS, Brown, SJ, Ridd, MJ, Lawton, S, Simpson, EL, Cork, MJ, Sach, TH, Flohr, C, Mitchell, EJ, Swinden, R, Tarr, S, Davies-Jones, S, Jay, N, Kelleher, M, Perkin, MR, Boyle, R, Williams, HC, On behalf of the BEEP study team |
| Rok vydání: |
2019 |
| Předmět: |
|
| Popis: |
Background Skin barrier dysfunction precedes eczema development. We tested whether daily emollient in the first year can prevent eczema in high-risk children. Methods We conducted a UK, multicentre, pragmatic, 2-arm, parallel-group randomised controlled trial. Term newborns with family history of atopic disease were randomised (1:1) to apply emollient daily (Diprobase cream® or DoubleBase® gel®) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (controls). Research nurses assessing outcomes at 2-years were masked to allocation. Primary outcome was eczema at 2 years (UK working party criteria) with analysis as randomised regardless of adherence to allocation and adjusting for stratification variables. Trial registration: ISRCTN21528841. Findings 1394 newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months in those with complete data. At 2 years, eczema was present in 139/598 (23%) children in the emollient group and 150/612 (25%) in controls, adjusted relative risk 0·95, 95% CI 0·78 to 1·16, p=0·61 and adjusted risk difference -1·2%, 95% CI -5·9% to 3·6%. Other eczema definitions supported the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (SD 0·46) in controls; adjusted incidence rate ratio 1·55 95% CI 1·15 to 2·09. Interpretation We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Funding National Institute for Health Research Health Technology Assessment (12/67/12) funded the main trial. Supplementary funding for food allergy assessments was from Goldman Sachs Gives and the Sheffield Children’s Hospital Charity. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
