Softened Water for Eczema Prevention Pilot Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Eczema

Intervention / Treatment
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* Device: Domestic ion-exchange water softener


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever) Mother aged ≥18 years of age at enrolment Baby <36 weeks gestation at screening Informed consent from the mother on behalf of the participant Mother has the ability to understand English Live in a hard water area (>250 mg/L Calcium Carbonate) Consent of landlord for installation on water softener (if appropriate) Occupy a property appropriate for installation of a water softener Exclusion Criteria: Preterm birth (defined as birth prior to 37 weeks gestation) Significant inflammatory skin disease at birth not including seborrheic dermatitis (cradle cap) Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial. The child is to be fostered/adopted Any immunodeficiency disorder or severe genetic skin disorder Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial. Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period Water softening or filtration device already installed Concurrent enrolment in any other skin-related intervention study Other medical condition that in the opinion of the CI could interfere with the conduct of the trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Domestic ion-exchange water softener<br>The intervention group will have a domestic ion-exchange water softener installed prior to birth. | Device: Domestic ion-exchange water softener<br>* 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.<br>|
| No Intervention: Usual hard water supply<br>The control group will receive their usual domestic water supply. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion 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). | Before birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pregnant women approached who agree to be screened |  | 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) |  | Before birth | 
| Proportion of families randomised that withdraw due to infant ineligibility |  | Baseline (birth) | 
| Proportion of families in intervention arm who found the intervention acceptable |  | 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) | 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 |  | 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 | Baseline, 4 weeks, 3 and 6 months | 
| Proportion of water samples with hardness >20 mg/L calcium carbonate | Would suggest failure of the water softening device | Between installation and end of follow up | 
| Proportion of participants that withdraw from the trial prior to end of follow up |  | From randomisation until end of follow up | 
| Median number of nights spent away from the participant's main home during follow up |  | From birth until end of follow up (6 months of age) | 
| Proportion of clinical outcome assessments that have remained blinded |  | at 4 weeks, 3 & 6 months | 
| Proportion with patient-reported, doctor-diagnosed eczema |  | by 6 months of age | 
| Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol |  | 4 weeks, 3 & 6 months | 
| Severity of eczema (if present) using Eczema Area and Severity Index (EASI) |  | 4 weeks, 3 & 6 months | 
| Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM) |  | Monthly from 4 weeks to 6 months of age | 
| Time to onset of patient-reported doctor-diagnosed eczema |  | from birth to end of follow up (6 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Water hardness, Atopic eczema prevention, Skin barrier function, Skin microbiome