Softened Water for Eczema Prevention Pilot Trial (SOFTER)
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|ClinicalTrials.gov Identifier: NCT03270566|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atopic Eczema||Device: Domestic ion-exchange water softener||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Domestic ion-exchange water softener
The intervention group will have a domestic ion-exchange water softener installed prior to birth.
Device: Domestic ion-exchange water softener
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.
No Intervention: Usual hard water supply
The control group will receive their usual domestic water supply.
- Proportion of eligible families screened who are willing and able to be randomised. [ Time Frame: Before birth ]This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).
- 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 [ Time Frame: End of follow up (6 months of age) ](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)
- 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 [ Time Frame: Baseline, 4 weeks, 3 and 6 months ]According to UK diagnostic criteria-based photographic protocol
- Proportion of water samples with hardness >20 mg/L calcium carbonate [ Time Frame: Between installation and end of follow up ]Would suggest failure of the water softening device
- 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) ]
- Transepidermal water loss (TEWL) [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Cutaneous cytokine profiles [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]e.g. interleukin-1 levels
- Natural moisturising factor (NMF) levels [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Shannon Diversity Index and other skin and respiratory microbiota parameters [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Proportion with filaggrin null mutations [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Effect of filaggrin (FLG) gene mutation status on TEWL, cytokine levels, NMF levels and skin microbiota diversity [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Median domestic water hardness level (calcium carbonate concentration) [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
- Skin hydration [ Time Frame: at birth, 4 weeks, 3 & 6 months oif age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270566
|Contact: Zarif Jabbar-Lopez, MPH, MRCP||020 7188 7188 ext firstname.lastname@example.org|
|St Thomas' Hospital||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Zarif Jabbar-Lopez, MPH MRCP 02071887188 ext 57716 email@example.com|
|Principal Investigator:||Carsten Flohr, PhD, FRCPCH||King's College London|