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Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT
Lucy E Bradshaw1, Laura A Wyatt1, Sara J Brown2,3
1Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
Insights
Daily emollient use in the first year of life did not prevent eczema in high-risk infants. This practice was linked to increased skin infections and potential food allergies, showing no cost-effectiveness for eczema prevention.
Area of Science:
- Dermatology
- Pediatrics
- Allergy Immunology
Background:
- Atopic eczema is a prevalent childhood condition associated with asthma, allergic rhinitis, and food allergies, significantly impacting quality of life.
- Early identification of preventative strategies for atopic diseases in high-risk infants is crucial.
Purpose of the Study:
- To investigate the efficacy of daily emollient application in the first year of life for preventing eczema and other atopic diseases in high-risk newborns.
- To assess the safety and cost-effectiveness of this preventative approach.
Main Methods:
- A multicentre, randomized controlled trial involving 1,394 high-risk newborns.
- Infants were assigned to receive daily whole-body emollient application or standard skin-care advice for the first year.
- Primary outcome was eczema diagnosis at age 2 years, with secondary outcomes including other atopic diseases, safety, and cost-effectiveness, followed up to age 5 years.
Main Results:
- No significant difference in eczema prevalence was observed at age 2 years between the emollient group (23%) and the control group (25%).
- Emollient use was associated with a higher incidence of skin infections (adjusted IRR 1.55) and a potential increase in food allergies (aRR 1.47).
- No differences in atopic diseases were noted up to age 5 years, and the intervention was deemed not cost-effective.
Conclusions:
- Daily emollient application in the first year of life does not appear to prevent eczema in high-risk infants.
- The practice may increase the risk of skin infections and potentially food allergies.
- Current evidence suggests emollient use is not a cost-effective strategy for preventing atopic eczema in this population.
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.
