Title: Development and feasibility testing of an intervention to prevent potentially harmful skincare practices during infancy
Funder: Department of Health and Social Care

Abstract: Research question Is it possible to develop an intervention which will reduce infant bathing frequency and then test this in a randomised controlled trial. Background Eczema affects 15% of infants and young children in England and carries the highest global burden of any skin disease. Eczema is the visible manifestation of an impaired skin barrier. A key environmental risk factor for skin barrier damage is bathing. Bathing, even in tap water alone, disrupts skin physiology, increasing naturally acidic skin pH, removing protective lipids from the skin surface and altering enzymatic activity in the upper epidermis. Bathing with wash products such as soaps causes significantly more skin barrier damage than bathing in water alone. Aims and Objectives Work with pregnant women and their families to develop an acceptable intervention which aims to reduce infant bathing frequency and intensity. Undertake a randomised controlled feasibility trial to estimate the proportion of eligible families willing to be randomised to the intervention, their adherence to the intervention and its acceptability. Methods Initial qualitative work will involve the recruitment of at least 20 pregnant women and other family members who will be involved in caring for their infant. Semi-structured interviews will be undertaken. Transcripts will be analysed using thematic analysis to identify the factors influencing infant bathing behaviours, including bathing frequency, duration, temperature and use of wash products. Barriers and facilitators to interventions for reducing infant bathing frequency and intensity will be identified during the interviews; and will be used to determine what form an intervention might need to take. The suitability of such an intervention will be reviewed in a workshop attended by experts and patient representatives. A focus group of pregnant women and their families will then provide feedback on the acceptability of the intervention. Following the qualitative work, we will recruit 125 pregnant women to undertake a feasibility randomised controlled trial of the intervention. Infants will be followed up to six months of age. Lastly, we will invite 20 representative families from the feasibility trial to participate in qualitative interviews identifying views and barriers related to recruitment and adherence to the trial intervention. Timelines for delivery This project is scheduled to last 30 months and commence in March 2022. The initial qualitative work will last 9 months, followed by a 12-month period of recruitment to the feasibility study and follow up to 6 months of age, with trial data analysis, write up and dissemination taking place in the last 3 months of the project. Anticipated Impact and Dissemination A simple intervention that prevents infants developing eczema would be an important advance in population health. If the intervention proves successful, we will proceed in the latter stages of this project with the development of a protocol for a large scale, multi-centre, randomised controlled trial of the intervention with a view to seeking funding for this from the NIHR.

Lay abstract: Eczema is a dry, itchy skin condition affecting 15% of infants and young children, with a disproportionately high burden on children from ethnic minorities. Eczema has a significant impact on quality of life and is not currently preventable or curable. Whilst genetic factors which damage the skin barrier play a part in eczema emerging, the increase in eczema during the twentieth century means environmental factors must also be important. Because most eczema genes cause a damaged skin barrier, and we know that bathing babies can damage the skin barrier too, we want to find out whether advising families to bathe their babies less often and less intensively might stop babies getting eczema. Currently about one in three babies in England is bathed at least once daily, often using soaps, which is much more often than people used to bathe babies before they had ready access to hot water. Water and soaps can both damage baby skin and recent research findings suggest that reducing bathing frequency might be an effective way to prevent babies developing eczema. Before we can prove whether or not changing bathing practices might prevent eczema, we first need to work out how to persuade families to change their baby bathing routine. In this project, we will find out how families feel about taking part in a trial that aims to reduce potentially harmful baby skincare practices such as frequent bathing and use of soaps. Through interviews and focus groups with diverse groups of expectant mothers and their families, including those with and without other children, we will seek to identify which practices families might be willing to change, and any potential barriers to changing baby skincare practices. We will then design an intervention to reduce bathing frequency and test whether it is possible to do a clinical trial to find out whether the intervention prevents eczema. In this second phase of the project, we will recruit 125 pregnant women to be randomly assigned to either the new baby skincare intervention or to routine NHS advice. This study will aim to establish whether a trial testing the new way of advising families to reduce potentially harmful baby skincare practices is feasible. We will interview some of the participants in this study, after they have completed it, to learn about how they found the process of trial participation and their experiences of trying to reduce potentially harmful baby skincare practices. This will help us determine whether it will be possible to subsequently undertake a large randomised trial to investigate the effect of advice to reduce harmful skincare practices on eczema development. We have incorporated advice from the Centre for Evidence Based Dermatology patient panel in this study proposal.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: SKIN