Softened Water for Eczema Prevention (SOFTER)
Research type
Research Study
Full title
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
IRAS ID
233005
Contact name
Carsten Flohr
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Eczema is a common, itchy skin condition that can have a big impact on people's lives. Eczema is more common in infants who live in a hard water area and in this study we are testing whether installing water softeners in the homes of newborn babies can reduce their risk of developing eczema. We will do this by recruiting 80 pregnant women with a personal or family history of eczema, asthma or hayfever living in hard water areas. We will install water softeners in the homes of half of the participants. The other half will continue to receive their usual hard water supply. In order to ensure a fair evaluation of the water softeners, the decision about which group participants will be assigned to will be decided by chance using a computer (randomisation). We will closely monitor the babies for sigs of eczema until they are 6 months old. During this time we will perform several skin measurements to learn more about how hard water might cause changes in the skin that lead to eczema. This pilot study will help to inform the design and conduct of a larger, definitive trial to show whether installing waters softeners around the time of birth reduces the risk of eczema in infants.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0661
Date of REC Opinion
9 Jan 2018
REC opinion
Further Information Favourable Opinion