Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Proportion of families willing to be randomized.
研究概览
简要总结
The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.
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
- 年龄范围
- 1 Minute 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
- •Infant in overall good health
- •Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
- •Capable of giving informed consent
排除标准
- •Preterm birth defined as birth prior to 37 weeks gestation
- •Major congenital anomaly
- •Hydrops fetalis
- •Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
- •Any immunodeficiency disorder or severe genetic skin disorder
- •Any other serious condition that would make the use of emollients inadvisable
- •Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention
研究组 & 干预措施
Intervention (moisturizer group)
One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
干预措施: Sunflower oil (Drug)
Intervention (moisturizer group)
One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
干预措施: Aquaphor ointment (Drug)
Intervention (moisturizer group)
One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
干预措施: Cetaphil cream (Drug)
Control group (no moisturizers)
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
干预措施: Control group (Drug)
结局指标
主要结局
Proportion of families willing to be randomized.
时间窗: 6 months
Determine proportion of families willing to be randomized in order to design larger study in the future.
次要结局
- Proportion of families eligible for the trial, willing to participate(6 months)
- Proportion of families who found the interventions acceptable(6 months)
- Reported adherence with intervention(6 months)
- Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised(6 months)
- Amount of contamination as a result of increased awareness in the control group(6 months)
- Percentage of missing data and early withdrawal rates(6 months)
- Incidence of emollient-related adverse events(6 months)
- Incidence of eczema at 6 and 12 months(12 months)
- Age at onset of eczema(6 months)
- Filaggrin mutation status(6 months)