Status:
UNKNOWN
Softened Water for Eczema Prevention Pilot Trial
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
University of Nottingham
Conditions:
Atopic Eczema
Eligibility:
All Genders
Phase:
NA
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03270566
Start Date
February 12 2018
End Date
June 1 2019
Last Update
February 19 2018
Active Locations (1)
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1
St Thomas' Hospital
London, United Kingdom, SE1 7EH