Management of eczema in children aged between 3 months and 2 years Skin and Connective Tissue Diseases
Conditions
Interventions
Participants are randomised on a 1:1 basis using an online randomisation system.
Group 1 - Intervention. Participants are given skin prick test-guided dietary advice for four study foods (cow's milk,
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 3 months and less than 2 years 2. Have eczema diagnosed by an appropriately qualified healthcare professional 3. Have mild, moderate or severe eczema (Patient Orientated Eczema Measure (POEM) score >2 within the previous 28 days) 4. Be accompanied by an adult who is able to give consent
Exclusion criteria
Exclusion criteria: 1. Confirmed or probable* immediate (IgE-type) food allergy to the study foods 2. Previous skin prick test (SPT) or IgE blood test for the study foods 3. Another child in the household already taking part in the trial * Parents who report symptoms, which in the opinion of the allergy panel/their GP, are suspicious of an immediate-type reaction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema control measured using the caregiver-reported version of RECap for AtoPic eczema (RECAP) questionnaire collected four-weekly for 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eczema control measured using the caregiver-reported version of RECap for AtoPic eczema (RECAP) questionnaire at 28 weeks, 32 weeks and 36 weeks 2. Eczema symptoms measured using a Patient-Oriented Eczema Measure (POEM) questionnaire four-weekly for 36 weeks 3. Itch severity measured using Numerical Rating Scale Peak Pruritis during the last 24 hours (PP-NRS) questionnaire four-weekly for 36 weeks 4. Eczema severity measured using Global eczema severity score four-weekly for 36 weeks 5. Eczema signs measured using Eczema Area Severity Index (EASI) at baseline and 24 weeks 6. Child quality of life (disease-specific) measured using an Infant Dermatitis Quality of Life (IDQOL) questionnaire at baseline, 24 weeks and 36 weeks 7. Child quality of life (generic) measured using Child Health Utility 9D scale (CHU-9D) questionnaire at baseline, 12 weeks, 24 weeks and 36 weeks 8. Growth of children measured using calculation of head circumference, weight-for-age, stature-for-age, and weight-for-stature at baseline and 24 weeks 9. Parent quality of life measured using the EuroQol-5 Dimension (EQ-5D-5L) and EQ-VAS questionnaires at baseline, 12 weeks, 24 weeks and 36 weeks 10. Parent quality of life measured using the Care Related Quality of Life (CarerQol) questionnaire at baseline, 24 weeks and 36 weeks 11. Parental anxiety measured using a Generalised Anxiety Disorder 7 (GAD-7) questionnaire at baseline, 24 weeks and 36 weeks 12. Breastfeeding status of the mother measured using questions from the Infant Feeding Survey four-weekly for 36 weeks 13. Healthcare resource use measured using the Resource Use Measure (RUM, including ModRUM and bespoke questions) at 12 weeks, 24 weeks and 36 weeks 14. Ingestion of study foods measured using a bespoke questionnaire four-weekly for 36 weeks 15. Use of topical treatments for eczema measured using a bespoke questionnaire four-weekly for 36 weeks 16. Eczema/food allergy genes measured in an optional DNA saliva sample measured using LG | — |
Countries
England, United Kingdom
Outcome results
None listed