Prevention of eczema Skin and Connective Tissue Diseases
Conditions
Interventions
This study is part of a feasibility study program consisting of four work packages:
• Work package 1: Identifying what can be changed: Qualitative work with families/carers to identify potential barri
Sponsors
St George's, University of London
Eligibility
Sex/Gender
Female
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy, singleton pregnancy 2. Child has a first-degree relative with a parentally reported, doctor diagnosis of eczema, hay fever or asthma. 3. Mother aged =16 years old 4. Consenting adult has the ability to understand English
Exclusion criteria
Exclusion criteria: 1. Expected preterm birth (defined as birth prior to 37 weeks gestation) 2. Sibling previously randomised into this trial 3. Severe known health issues in the developing infant which, at parent or investigator discretion, would make it difficult for the family to take part in the trial 4. Any antenatally diagnosed condition that would make the use of emollient inadvisable or not possible 5. Enrolled in another clinical study which requirements that are likely to conflict with the provisions of this feasibility randomised trial directly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of eligible families willing to be randomised: a ratio of the number of families who are randomised to the number of eligible families who review the trial information sheet, to be measured at the end of trial recruitment | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes 1. Presence of eczema, defined using an adaptation of the validated UK Working Party Diagnostic Criteria for Atopic Dermatitis to reflect the young age group included in the study, clinically examined by a blinded investigator (clinician) and recorded in the trial CRF at the final 6-month assessment 2. Trans-Epidermal Water Loss, measured at 6 months Feasibility outcomes 1. Reported adherence to the intervention. Each infant bath will be recorded by participating dynamically on the Study MyCap app which links to the REDCap study database. Bathing frequency over the 6 months follow-up period will be determined from the REDCap database. 2. Acceptability of the intervention to participating families. Measured using questions on acceptability corresponding to the seven domains of the Theoretical Framework of Acceptability (TFA): Affective attitude, Burden, Intervention coherence, Perceived effectiveness, Self-efficacy, Opportunity costs, and Ethicality. Responses rated on a Likert scale to express the level of agreement with each statement. Questions are administered in the 6-month questionnaire. 3. Proportion of the control group accessing the intervention. Control group participants will be asked if they discussed the intervention advice with anyone in the active arm or watched the intervention group’s video. Questions are administered in the 6-month questionnaire. 4. Ascertainment bias of the blinded investigator outcome assessments that become unblinded to treatment allocation. Questions are completed by clinical undertaking the outcome assessments in the 6-month questionnaire. 5. Loss to follow up. The proportion of enrolled participants who do not undergo the 6-month visit. 6. Completeness of eczema outcome (see clinical outcome) at age 6 months. The proportion of enrolled participants who have the clinical outcome undertaken. 7. Adverse events which might potentially be related to reducing the bathing frequency, including skin infections, omph | — |
Countries
England, United Kingdom
Outcome results
None listed