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BabyBathe study protocol: A randomised controlled feasibility trial to change baby bathing practice during the first months of life

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posted on 2024-02-01, 17:20 authored by Michael PerkinMichael Perkin, Michael Ussher, Lucy GoldsmithLucy Goldsmith, Carsten Fiohr, Amanda Roberts, Victoria Cornelius, Charlotte WahlichCharlotte Wahlich, Kathryn WillisKathryn Willis, Robert J Boyle

Introduction: Atopic eczema causes the highest global burden of all skin diseases and affects up to 15% of infants and 6% of older children. Environmental factors are believed to play an important role in the aetiology of skin barrier impairment and subsequent eczema in infancy. Bathing, even with tap water alone, adversely affects skin physiology and may be a key environmental risk factor for eczema in infancy.

Methods and analysis: We will work with pregnant women and their families to develop an acceptable intervention which aims to reduce infant bathing frequency and intensity. We will then undertake a randomised controlled feasibility trial recruiting 125 pregnant women from one hospital site in London, England. The sample size was rounded up and participants will be randomised at a ratio of 1:1 to the intervention advising reduced bathing frequency and intensity, with an associated reduction in use of wash products, versus standard care. The feasibility trial outcomes include: the proportion of eligible families willing to be randomised; reported adherence and acceptability of the intervention; contamination of the control group; unblinding of outcome assessments and loss to follow up. The clinical outcome will be the presence of eczema at six months of age assessed using a modified form of the UK Working Party Diagnostic Criteria for Atopic Dermatitis.

Ethics and dissemination: Ethical approval has been obtained from the North of Scotland Research Ethics Committee (22/NS/0120). Data analysis, interpretation and conclusions will be presented at national and international conferences, published in peer reviewed journals and disseminated via social media, patient charities and support groups.

Trial Registration: ISCTRN registration 10.1186/ISRCTN51491794

Funding

NIHR Research for Patient Benefit programme (NIHR203170)

History

Research Institute

  • Population Health

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