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Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial
Joanne R Chalmers1, Rachel H Haines2, Lucy E Bradshaw2
1Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
Insights
Daily emollient use in the first year did not prevent eczema in high-risk infants. The study suggests a potential increased risk of skin infections with emollient application in newborns.
Area of Science:
- Dermatology
- Pediatrics
- Clinical Trials
Background:
- Skin barrier dysfunction is a precursor to eczema development.
- Infants at high risk for eczema often have a family history of atopic diseases.
Purpose of the Study:
- To investigate if daily emollient application in the first year of life can prevent eczema in high-risk newborns.
- To assess the efficacy of emollients in reducing eczema incidence in infants with a predisposition to atopic conditions.
Main Methods:
- A multicentre, pragmatic, randomized controlled trial involving 1394 newborns at high risk for eczema.
- Infants were assigned to daily emollient application or standard skin-care advice for the first year.
- Eczema incidence was assessed at age 2 years using UK working party criteria.
Main Results:
- No significant difference in eczema prevalence at age 2 years between the emollient and control groups (23% vs 25%).
- The adjusted relative risk for eczema was 0.95 (95% CI 0.78 to 1.16), indicating no preventative effect.
- An increased incidence rate of skin infections was observed in the emollient group (IRR 1.55, 95% CI 1.15 to 2.09).
Conclusions:
- Daily emollient use in the first year of life does not prevent eczema in high-risk children.
- Evidence suggests a potential increased risk of skin infections associated with routine emollient application in newborns.
- Routine emollient use is not recommended for eczema prevention in newborns with a family history of eczema, asthma, or allergic rhinitis.
Background:
Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.
Methods:
We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.
Findings:
1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of 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 (0·46) in the control group; 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. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.
Funding:
National Institute for Health Research Health Technology Assessment.
