Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.
研究概览
简要总结
Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.
详细描述
This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.
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
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
- •parental consent must be obtained
排除标准
- •infants being admitted for major surgical procedure which is attended by high rate of infectious complications
- •clinically-evident skin infection
- •generalized skin disease
- •structural defect of the skin involving greater than 5% of the body surface
- •with a major congenital anomaly
- •with a known immunodeficiency
结局指标
主要结局
Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.
次要结局
未报告次要终点