Barrier Enhancement for Eczema Prevention

University of Nottingham1,394 enrolled

Overview

The primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,394

Conditions

Eczema

Interventions

Experimental (Doublebase Gel® or Diprobase Cream®)OTHER

Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.

Best practice skin care advice bookletOTHER

This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.

Eligibility

Sex: ALLMax age: 21 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma * child up to 21 days old * consenting adult has the ability to understand English Exclusion Criteria: * preterm birth (defined as birth prior to 37 weeks gestation) * sibling (including twin) previously randomized to this trial. If multiple births, the first child will be randomized into the trial. * child has a severe widespread skin condition that would make the detection and/or assessment or 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

Locations (16)

School of Social and Community Medicine, University of Bristol

Bristol, United Kingdom

Queens Hospital

Burton, United Kingdom

Derby Childrens Hosptia

Outcomes

Primary Outcomes

A diagnosis of eczema between 12 and 24 months of age (defined as meeting the United Kingdom (UK) Working Party Diagnostic Criteria for Atopic Dermatitis).

To reflect the chronicity of eczema, these criteria refer to signs and symptoms present over the past year. Applying the criteria at 24 months of age will therefore detect eczema present only between the ages of 12 and 24 months, thus excluding transient eczematous rashes which are common in the first year of life and often reported by parents as "eczema" but less likely to be true atopic eczema

Time frame: 24 months

Secondary Outcomes

Presence of parental report of eczema between birth and 24 months.

Assessed using: Any parental report of a clinical diagnosis of eczema. Completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis at 12 and 24 months.

Time frame: Up to 24 months

Presence of visible eczema at 24 months (skin examination by researcher).

Time frame: 24 months

Time to onset of eczema

First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.

Time frame: 24 months

Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis

Parental reported wheezing and allergic rhinitis between 12 and 24 months. Parental report of a clinical diagnosis of food allergy at 12 and 24 months. Parental report of food allergy at 12 and 24 months. Parents will be specifically questioned about cow's milk, egg, peanuts, and other nuts plus "any other food". Allergic sensitisation at 24 months to any of the following common allergens: milk, egg, peanut, cat, grass pollen, house dust mite. Confirmed diagnosis of food allergy at 24 months to milk, egg, peanut or 'any of milk, egg or peanut'. The diagnosis is derived from a combination of parental report, allergic sensitisation and food challenge.

Data from ClinicalTrials.gov

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