Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Skin flora reduction across treatment groups
研究概览
简要总结
The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.
详细描述
Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. The mechanism of action for this observed benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine.
Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. A small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •babies born at Tribhuvan University Teaching Hospital
- •greater than 1500 grams
排除标准
- •less than 1500 grams
- •requires major surgical procedure
- •clinically evident skin infection
- •generalized skin disease
- •major congenital anomoly
结局指标
主要结局
Skin flora reduction across treatment groups
时间窗: prior to wipe, 2hrs after, and 24hrs after
次要结局
- Serum concentrations of chlorhexidine 24 hours after wipe(24 hrs after wipe)
