Feasibility testing of an intervention to prevent potentially harmful skincare practices during infancy
Prevention of eczema
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 barriers and facilitators to the intervention • Work package 2: Co-designing the intervention: Analysis and expert panel to identify intervention components and focus group/walkthroughs with families to assess acceptability and refine intervention materials • Work package 3 (This Study): Randomised controlled feasibility trial. Pregnant women will be recruited at their 36-week antenatal scan. • Work package 4: In-depth exploration of acceptability of and adherence to the intervention: interviews/focus groups with families receiving the intervention and with health professionals delivering the intervention If the feasibility trial is successful then a proposal to undertake a full-scale randomised controlled trial will follow. This study is work package 3: Intervention group: Reducing infant bathing frequency to no more than 1/week through to six months of age Control group: Infant bathing frequency as per family’s preference Randomisation: Participants will be randomised using the REDCap Randomization Module set up by the study statistician with all other study members blinded to allocation. Modes of delivery: Intervention Group: • Intervention group-specific booklet • Wallchart (for recording when the infant is bathed) • Plastic “day of the week” bookmarks to remind the family when the last bath took place • Study reminders (fridge magnet and a bookmark) to remind families of the key aims of the intervention group. • Intervention Group specific study webpage • Intervention Group study video Control Group: • Control group-specific booklet • Study reminders (fridge magnet and a bookmark) to remind families of the key aims of the control group. • Control Group specific study webpage Duration of intervention and follow-up: Through to six months of age
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
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