Barrier Enhancement for Eczema Prevention

Primary outcome measure as of 08/12/2016:
Diagnosis of eczema between 12 and 24 months of age defined as meeting the UK Working Party Diagnostic criteria).

Original primary outcome measure:
Parent reported - UK Working Party Diagnosic Criteria for atopic deramtitis; Timepoint(s): 12 & 24 months

Secondary outcome measures as of 08/12/2016:
1. Presence of eczema between birth and 24 months is assessed using:
1.1. Any parental report of a clinical diagnosis of eczema
1.2. Completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis at 12 and 24 months
2. Presence of visible eczema at 24 months (skin examination by researcher)
3. Time to onset of eczema is assessed using:
3.1. First parental report of a clinical diagnosis of eczema
3.2. First topical corticosteroid and /or immunosuppressant prescription for eczema
4. Severity of eczema is assessed using EASI at 24 months and POEM*at 12 and 24 months
5. Presence of other allergic diseases:
5.1. Parental reported wheezing and allergic rhinitis between 12 and 24 months
5.2. Parental report of a clinical diagnosis of food allergy at 12 and 24 months
5.3. 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”.
5.4. Allergic sensitisation at 24 months to any of the following common allergens: milk, egg, peanut, cat, grass pollen, house dust mite.
5.5. 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.
6. Health-related quality of life is measured using CHU-9D at 24 months in order to estimate QALYs and parental quality of life measured using the EQ-5D-5L at baseline and 24 months in order to estimate the change in parental QALYs, if any
7. Health economic outcomes:
7.1. Health care resource use at 3, 6, 12, 18 and 24 months.
7.2. Cost-effectiveness and cost-utility at 24 months (combining health resource use and health-related quality of life outcomes).

Original secondary outcome measures:
1. EASI - Eczema Area and Severity Index; Timepoint(s): 24 months
2. EQ5D-5L - Parental quality of life; Timepoint(s): Baseline and 24 months
3. IDQoL - Infant Dermatitis Quality of Life; Timepoint(s): 24 months
4. POEM - Patient-oriented eczema measure; Timepoint(s): 12 and 24 months

Added 01/02/2022:
Tertiary outcome measures*
1. Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema
2. Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months
3. Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis
4. Severity of eczema at 36, 48, and 60 months as measured by POEM
5. Parental reported wheezing, at 36, 48 and 60 months
6. Parental reported allergic rhinitis at 36, 48 and 60 months
7. Parental reported food allergy symptoms at 36, 48 and 60 months
8. Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months
9. Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months
10. CHU-9D at 36, 48 and 60 months in order to estimate QALYs
11. Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs
12. Health care resource use at 36, 48 and 60 months
13. Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)
14. Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months
15. Parental report of clinical diagnosis of food allergy by 60 months

*Details of the analyses of the tertiary outcomes were added by the trial statistician after the analysis of the primary and secondary outcomes at which point, the investigators, trial management, data management and statisticians were aware of the results.