NCT04325451进行中（未招募）不适用
An Observational Study to Determine Lifestyle, Biophysical and Environmental Risk Factors in the Development of Early-onset Pediatric Atopic Dermatitis
MYOR Ltd.2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2020年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
研究概览
简要总结
Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. However, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. Such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop AD, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Hours 至 120 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment
- •Term and near term newborns born between 34+0 and 42+0 weeks gestational age
- •Mothers must be aged >18 years
- •Parents' ability to complete questionnaire(s) at defined times throughout study duration
- •Parents or legal guardian provide informed written consent
排除标准
- •Preterm birth prior to 34+0 weeks gestation
- •Less than 12 hours out of the incubator
- •Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
- •Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
- •Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
- •Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
结局指标
主要结局
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
时间窗: 24 months
Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
次要结局
- To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at six months of age.(6 months)
- To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at two years of age.(24 months)
- To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD(24 months)
- To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies(24 months)
- 3. To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the age of onset of AD(24 months)
- To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis(12 months)
- To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies(24 months)
- To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of development AD at one year of age(12 months)
研究者
研究点 (2)
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