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
A 6-month parallel group assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of eczema in neonates, with an embedded mechanistic study. The overall rationale is that by installing a domestic water softener around the time of birth, the infant will be exposed to softened water rather than hard water for bathing and that this will be less irritating to the skin than hard water and so associated with a lower risk of eczema development. The primary objective is to determine the feasibility of conducting a subsequent definitive RCT that will investigate whether installation of a domestic water softener around the time of birth can prevent eczema in high-risk babies. The secondary objective is to explore the likely mechanisms by which water softeners might prevent eczema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
Ion-exchange water softeners exchange calcium and magnesium, amongst other divalent cations, for monovalent sodium cations using a polystyrene resin. The sodium ions come from sodium chloride (common salt). The salt needs to be topped up every 3-4 weeks and sufficient quantities of block salt will be supplied to participants. The water softener used in this study does not require electricity and has two cylinders of resin which are used alternately. A control valve alternates the flow between the two cylinders and ensures a constant supply of regenerated resin. Ion-exchange water softeners typically reduce downstream water hardness to close to zero.
St Thomas' Hospital
London, United Kingdom
RECRUITINGProportion of eligible families screened who are willing and able to be randomised.
This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).
Time frame: Before birth
Proportion of pregnant women approached who agree to be screened
Time frame: Before birth
Proportion of families eligible on screening that cannot have a water softener installed (e.g. due to landlord or local authority refusal, technical (plumbing) reasons)
Time frame: Before birth
Proportion of families randomised that withdraw due to infant ineligibility
Time frame: Baseline (birth)
Proportion of families in intervention arm who found the intervention acceptable
Time frame: End of follow up (6 months of age)
Proportion of participants in control arm that become exposed to softened water
(e.g. by moving to a new home in a soft water area, or moving to a home with an active water softener installed, before the end of follow up)
Time frame: End of follow up (6 months of age)
Proportion of participants that have the water softening unit removed or disabled prior to end of follow up
Time frame: End of follow up (6 months of age)
Proportion of participants with visible eczema status (yes/no) recorded
According to UK diagnostic criteria-based photographic protocol
Time frame: Baseline, 4 weeks, 3 and 6 months
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Proportion of water samples with hardness >20 mg/L calcium carbonate
Would suggest failure of the water softening device
Time frame: Between installation and end of follow up
Proportion of participants that withdraw from the trial prior to end of follow up
Time frame: From randomisation until end of follow up
Median number of nights spent away from the participant's main home during follow up
Time frame: From birth until end of follow up (6 months of age)
Proportion of clinical outcome assessments that have remained blinded
Time frame: at 4 weeks, 3 & 6 months
Proportion with patient-reported, doctor-diagnosed eczema
Time frame: by 6 months of age
Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol
Time frame: 4 weeks, 3 & 6 months
Severity of eczema (if present) using Eczema Area and Severity Index (EASI)
Time frame: 4 weeks, 3 & 6 months
Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)
Time frame: Monthly from 4 weeks to 6 months of age
Time to onset of patient-reported doctor-diagnosed eczema
Time frame: from birth to end of follow up (6 months of age)