Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial
Joanne R Chalmers,
Sanja Kezic,
Zarif K Jabbar-Lopez,
Nikeeta Gurung,
Danielle Greenblatt,
Annette Briley,
Kim Suzanne Thomas,
Tony Frost,
John E A Common,
Heidi H Kong,
Julie A Segre,
Simon Danby,
Michael J Cork,
Janet L Peacock,
Carsten Flohr
Affiliations
Joanne R Chalmers
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK
Sanja Kezic
Amsterdam UMC, University of Amsterdam, Public and Occupational Health, Netherlands Center for Occupational Diseases, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
Zarif K Jabbar-Lopez
1 Unit for Population-Based Dermatology Research, St John`s Institute of Dermatology, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Nikeeta Gurung
1 Unit for Population-Based Dermatology Research, St John`s Institute of Dermatology, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Danielle Greenblatt
1 Unit for Population-Based Dermatology Research, St John`s Institute of Dermatology, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Annette Briley
2 Women`s Health, King`s College London, London, UK
Kim Suzanne Thomas
Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK
Tony Frost
4 Aqua Focus, Shrewsbury, UK
John E A Common
6 Skin Research Institute of Singapore, A*STAR, Singapore, Singapore
Heidi H Kong
7 Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA
Julie A Segre
8 Translational and Functional Genomics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA
Simon Danby
9 Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Diseases, University of Sheffield Medical School, Sheffield, UK
Michael J Cork
9 Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Diseases, University of Sheffield Medical School, Sheffield, UK
Janet L Peacock
Department of Epidemiology, Geisel School of Medicine at Dartmouth, Dartmouth College, Hanover, New Hampshire, USA
Carsten Flohr
1 Unit for Population-Based Dermatology Research, St John`s Institute of Dermatology, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Introduction Atopic eczema affects 20% of UK children, and environmental factors are important in its aetiology. Several observational studies suggest an increased risk of atopic eczema in children living in hard water areas. The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy. A further aim is to explore the pathophysiological mechanisms for this in an embedded mechanistic study.Methods and analysis Multicentre parallel group assessor-blinded randomised controlled pilot trial. Participants are newborn babies (n=80) living in a hard water (>250 mg/L calcium carbonate) area at risk of developing atopic eczema because of a family history of atopy. Participants will be randomised prior to birth in a 1:1 ratio. The intervention group will have an ion-exchange water softener installed prior to birth. The control group will receive their usual domestic hard water supply. Follow-up will be until 6 months of age. Data will be collected at birth (baseline), 1, 3 and 6 months of age. The main outcome is the proportion of eligible families screened who are willing and able to be randomised. Several secondary feasibility and clinical endpoints will also be evaluated, alongside mechanistic outcomes. Data will be analysed on an intention-to-treat basis. There will be no hypothesis testing for the clinical outcomes. Study acceptability will be evaluated through semistructured interviews.Ethics and dissemination This study has been reviewed and given a favourable opinion by the North West–Liverpool East Research Ethics Committee (Ref: 17/NW/0661). The results of the study will be reported at international conferences and in peer-reviewed scientific journals. We will send participating families a summary of the pilot trial results.Trial registration number NCT03270566.
