Softened Water for Eczema Prevention Pilot Trial (SOFTER)

King's College London

Status

Unknown

Conditions

Atopic Eczema

Treatments

Device: Domestic ion-exchange water softener

Study type

Interventional

Funder types

Other

Identifiers

NCT03270566

IRAS 233005

Details and patient eligibility

About

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

Full description

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.

Enrollment

80 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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