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
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Proportion of eligible families screened who are willing and able to be randomised.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Domestic ion-exchange water softener
The intervention group will have a domestic ion-exchange water softener installed prior to birth.
干预措施: Domestic ion-exchange water softener (Device)
Usual hard water supply
The control group will receive their usual domestic water supply.
结局指标
主要结局
Proportion of eligible families screened who are willing and able to be randomised.
时间窗: Before birth
This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).
次要结局
- Proportion of participants with visible eczema status (yes/no) recorded(Baseline, 4 weeks, 3 and 6 months)
- Proportion of water samples with hardness >20 mg/L calcium carbonate(Between installation and end of follow up)
- Proportion with patient-reported, doctor-diagnosed eczema(by 6 months of age)
- Proportion of clinical outcome assessments that have remained blinded(at 4 weeks, 3 & 6 months)
- Proportion of families in intervention arm who found the intervention acceptable(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))
- 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)
- 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 participants in control arm that become exposed to softened water(End of follow up (6 months of age))
- Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol(4 weeks, 3 & 6 months)
- 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))
- Time to onset of patient-reported doctor-diagnosed eczema(from birth to end of follow up (6 months of age))