Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.

Autor:	Bradshaw LE; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Wyatt LA; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Brown SJ; Centre for Genomic and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.; Department of Dermatology, NHS Lothian, Edinburgh, UK., Haines RH; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Montgomery AA; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Perkin MR; Population Health Research Institute, St George's, University of London, London, UK., Sach TH; Health Economics Group, Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK., Lawton S; Rotherham NHS Foundation Trust, Rotherham, UK., Flohr C; Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK., Ridd MJ; Population Health Sciences, University of Bristol, Bristol, UK., Chalmers JR; Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK., Brooks J; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Swinden R; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Mitchell EJ; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Tarr S; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK., Jay N; Sheffield Children's Hospital, Sheffield, UK., Thomas KS; Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK., Allen H; National Heart and Lung Institute, Imperial College London, London, UK., Cork MJ; Sheffield Dermatology Research, Department of Infection and Immunity, University of Sheffield, Sheffield, UK., Kelleher MM; National Heart and Lung Institute, Imperial College London, London, UK., Simpson EL; Department of Dermatology, Oregon Health & Science University, Portland, Oregon, USA., Lartey ST; Health Economics Group, Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK., Davies-Jones S; Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK., Boyle RJ; Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.; National Heart and Lung Institute, Imperial College London, London, UK., Williams HC; Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
Jazyk:	angličtina
Zdroj:	Health technology assessment (Winchester, England) [Health Technol Assess] 2024 Jul; Vol. 28 (29), pp. 1-116.
DOI:	10.3310/RHDN9613
Abstrakt:	Background: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life. Objectives: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children. Design: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years. Setting: Twelve secondary and four primary care centres. Participants: Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery. Interventions: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation. Main Outcome Measures: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness. Results: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires. Limitations: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes. Conclusions: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context. Future Research: To pool similar studies in an individual patient data meta-analysis. Trial Registration: This trial is registered as ISRCTN21528841. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment ; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.
Databáze:	MEDLINE
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