Topic: Children, Primary Care, Dermatology
Conditions
Interventions
Participants are 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
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 08/12/2016: 1. Child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma. 2. Child up to 21 days old. 3. Mothers must be aged =16 years 4. Consenting adult has the ability to understand English. Original inclusion criteria: 1. Child has a first-degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma 2. Child in overall good health 3. Child up to three weeks old 4. Consenting adult has the ability to understand English
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 08/12/2016: 1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Sibling (including twin) previously randomised to this trial. If multiple birth the first child will be randomised into the trial 3. Child has a severe widespread skin condition that would make the detection and/or assessment of eczema difficult 4. 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 5. Any condition that would make the use of emollient inadvisable or not possible Original exclusion criteria: 1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Sibling (including twin) previously randomised to this trial 3. Child has serious health issues or a severe widespread skin condition 4. Any condition that would make the use of emollient inadvisable or not possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed