Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 1
- 主要终点
- Incidence of diaper dermatitis in newborns at home
研究概览
简要总结
Through the establishment of the newborn home skin care management system under the service of "WeChat platform+health care", the investigators focus on the common skin problems of newborns at home, push health education materials through the system, teach parents the methods and details of home skin care, and evaluate the effect of the system on reducing the incidence of newborn home skin problems and the prognosis of home skin problems through cluster randomized controlled research.
详细描述
In this study, the cluster randomization method is used, and eight centers are assigned to the experimental group or the control group according to the ratio of 1:1. Randomization plan is made by independent statistical team in statistical software: by creating random seed numbers and sorting them, the intervention plan distribution of each center is determined. The outcome evaluator and the statistical analysis team will not know the grouping situation of each center.
In this study, there are 4 centers in the experimental group and 4 centers in the control group. Sample size calculation is based on the main outcome index: the incidence of diaper dermatitis in newborns at home.
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 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns born in normal delivery (gestational age ≧35w)
- •Newborns' parents can cooperate, have certain learning, reading and understanding abilities, and have the ability to care for newborns
- •Voluntary participation in this study.
排除标准
- •Newborns requiring hospitalization.
- •Newborns diagnosed with congenital skin diseases.
- •The newborn mother has mental illness.
- •The newborn mother has a serious illness and needs hospitalization.
结局指标
主要结局
Incidence of diaper dermatitis in newborns at home
时间窗: Within two months after birth
The proportion of people with diaper dermatitis in the total number of people in the study.The diagnosis of diaper dermatitis is based on any rash in the diaper area reported by parents.
次要结局
- Rate of Hospital Visits for Skin Problems(Within two months after birth)
- Incidence rate of neonatal home atopic dermatitis (AD)(Within two months after birth)
- Parental Knowledge of Home Skincare(Within two months after birth)