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  • 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

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Dermatology
Protocol
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
  1. Zarif K Jabbar-Lopez1,
  2. Nikeeta Gurung1,
  3. Danielle Greenblatt1,
  4. Annette Briley2,
  5. Joanne R Chalmers3,
  6. Kim Suzanne Thomas3,
  7. Tony Frost4,
  8. Sanja Kezic5,
  9. John E A Common6,
  10. Heidi H Kong7,
  11. Julie A Segre8,
  12. Simon Danby9,
  13. Michael J Cork9,
  14. Janet L Peacock10,
  15. Carsten Flohr1
  1. 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
  2. 2 Women's Health, King's College London, London, UK
  3. 3 Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK
  4. 4 Aqua Focus, Shrewsbury, UK
  5. 5 Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  6. 6 Skin Research Institute of Singapore, A*STAR, Singapore, Singapore
  7. 7 Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA
  8. 8 Translational and Functional Genomics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA
  9. 9 Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Diseases, University of Sheffield Medical School, Sheffield, UK
  10. 10 School of Population Health and Environmental Sciences, King's College London, London, UK
  1. Correspondence to Professor Carsten Flohr; carsten.flohr{at}kcl.ac.uk

Abstract

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.

  • atopic eczema
  • water hardness
  • pilot trial
  • dermatology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027168

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    Footnotes

    • Contributors CF is the chief investigator with overall responsibility for the SOFTER pilot trial. He conceived the idea for the study, contributed to the writing of the trial protocol and reviewed this manuscript. ZKJL is the senior coinvestigator responsible for designing and running the SOFTER pilot trial. He led on the writing of the trial protocol and drafted the manuscript. JLP is the senior statistical advisor and contributed to the writing of the trial protocol and reviewed the manuscript. NG coordinates the study, reviewed the trial protocol and drafted the manuscript. DG, AB, JRC, KST, TF, SK, HHK, JAS, JEAC, SD and MJC were involved in finalising the study protocol and reviewing of the manuscript.

    • Funding Funding to conduct the trial is provided by the NIHR through a Career Development Fellowship (CF, chief investigator (CDF-2014-07-037)). The SOFTER trial is also supported by the NIHR Clinical Research Network, the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London as well as the Harvey Water Softeners, Woking, UK, who have agreed to cover the following costs: supply and installation of the water softening units, salt supplies and testing of the water samples.

    • Disclaimer The views expressed are those of the authors and not necessarily those of the UK National Health Service, the UK Department of Health and Social Care or the National Institute of Health Research.

    • Competing interests CF has received investigator-led research funding from Sanofi. His department has received clinical trial funding from Sanofi and AbbVie to test novel therapeutics in patients with paediatric atopic eczema. MJC is an investigator and consultant for Regeneron, Sanofi Genzyme, Pfizer, Leo, Galapagos, Novartis, Boots, L’Oreal, Dermavant, Menlo, Reckitt Benckiser, Oxagen, Johnson & Johnson, Hyphens, Astellas, Amlar, AbbVie, Galderma and Procter & Gamble. Harvey Water Softeners (HWS) contributed to the design and operational running of the study (supply and installation of water softeners, testing of water samples). Final decisions around design and conduct were made independently by investigators. HWS will not be involved in the analysis or interpretation of the results.

    • Patient consent for publication Not required.

    • Ethics approval North West–Liverpool East Research Ethics Committee (Ref: 17/NW/0661)

    • Provenance and peer review Not commissioned; externally peer reviewed.