Study name: BEEP Status: Preparing results
A randomised controlled trial to determine whether application of emollient from birth can prevent eczema in high risk children.
Contact:
BEEP@nottingham.ac.uk
Lead Investigator:
Professor Hywel Williams
What is the study about?
Emollients have long been used as a treatment for eczema; the BEEP study investigated whether emollients can be used preventatively. 1395 infants up to 21 days old who have a first-degree relative with eczema, hayfever, or asthma were recruited. The intervention was to apply an emollient, all-over, every day for the first year of the infant’s life in addition to standard skincare versus the control of standard skincare. The primary outcome was a diagnosis of eczema between 12 and 24 months of age (defined as meeting the UK Working Party Diagnostic criteria). Secondary outcomes were other measures of the development of eczema (parental report of a clinical diagnosis, parental completion of UK Working Party Diagnostic Criteria, and visible eczema at 2 years of age), severity of eczema, food allergy, allergic sensitization, presence of other allergic diseases, quality of life, health care resource use and cost effectiveness, and safety endpoints (slippages and skin infections).
Who can take part in the study?
Inclusion criteria:
- Child has a first degree relative with parental reported, doctor diagnosis of eczema, hay fever or asthma.
- Child up to 21 days old.
- Mothers must be aged ≥16 years.
- Consenting adult has the ability to understand English.
Exclusion criteria:
- Preterm birth (defined as birth prior to 37 weeks gestation).
- Sibling (including twin) previously randomised into this trial. If multiple births the first child will be randomised into the trial.
- Child has severe widespread skin condition that would make the detection and/or assessment of eczema difficult.
- Child has a serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.
- Any condition that would make the use of emollient inadvisable or not possible.
What is being tested in the study?
All parents will be given best practice infant skin care advice for their child. Those randomised to the intervention group will, in addition, be advised to apply emollient daily to the child’s entire body surface area for the first year of life.
Parents of children in the intervention group will be given a choice of two emollients (Doublebase Gel® and Diprobase Cream®) and may change between the two emollients throughout the trial if they wish.
What is this being compared to?
Best practice infant skin care advice for their child only.
What are we trying to find out?
The primary objective is to determine whether advising parents to apply emollient to their child’s skin for the first year of life in addition to best practice infant skin care advice can prevent the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.
Secondary objectives are to determine any difference in the time to onset of eczema, the severity of eczema, the risk of food allergy, the risk of allergic sensitisation to food or non-food allergens, the onset of other allergic diseases, safety issues associated with the emollient, cost effectiveness and long term effects of the intervention.
How many patients do we need?
1395
Funder:
NIHR - HTA
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