Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial

Abstract

Introduction: Bath emollients are widely prescribed for childhood eczema, yet evidence of their benefits over direct application of emollients is lacking. Objectives To determine the clinical and cost-effectiveness of adding bath emollient to the standard management of eczema in children

Methods and analysis: Design: Pragmatic open 2-armed parallel group randomised controlled trial. Setting: General practitioner (GP) practices in England and Wales. Participants: Children aged over 12?months and less than 12?years with eczema, excluding inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale). Interventions: Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only. Outcome measures: Primary outcome is long-term eczema severity, measured by the Patient-Oriented Eczema Measure (POEM) repeated weekly for 16?weeks. Secondary outcomes include: number of eczema exacerbations resulting in healthcare consultations over 1?year; eczema severity over 1?year; disease-specific and generic quality of life; medication use and healthcare resource use; cost-effectiveness. Aiming to detect a mean difference between groups of 2.0 (SD 7.0) in weekly POEM scores over 16?weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up, gives a total sample size of 423 children. We will use repeated measures analysis of covariance, or a mixed model, to analyse weekly POEM scores. We will control for possible confounders, including baseline eczema severity and child's age. Cost-effectiveness analysis will be carried out from a National Health Service (NHS) perspective.

Ethics and dissemination: This protocol was approved by Newcastle and North Tyneside 1 NRES committee 14/NE/0098. Follow-up will be completed in 2017. Findings will be disseminated to participants and carers, the public, dermatology and primary care journals, guideline developers and decision-makers.

Trial registration number: ISRCTN84102309.

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Identifiers

ORCID for Miriam Santer: orcid.org/0000-0001-7264-5260

ORCID for Kate Rumsby: orcid.org/0000-0002-8573-3718

ORCID for Nick A. Francis: orcid.org/0000-0001-8939-7312

ORCID for Beth Stuart: orcid.org/0000-0001-5432-7437

ORCID for Maria Chorozoglou: orcid.org/0000-0001-5070-4653

ORCID for Paul Little: orcid.org/0000-0003-3664-1873

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