Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36,911
- 试验地点
- 1
- 主要终点
- Neonatal Mortality
研究概览
简要总结
In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in
- Reduction in neonatal mortality (deaths in first 28 days of life)
- Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
- Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.
The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.
详细描述
Project Goal: The purpose of the trial is to evaluate the efficacy of cord cleansing with Chlorhexidine in the first 10 days of life in reducing neonatal mortality and morbidity. The study would provide a proof of principle for an intervention that could easily be scaled up.
Objectives of formative phase:
- Using TIPS (Trials of Improved Practices) methodology to evaluate the acceptance and impediments if any to practice of using liquid solution for cord cleaning including washing of hands with soap before and after use.
- To compare 3 modes (3 different packaging with application using cotton ball, dropper bottle and squeeze tube) of delivery for cord cleaning in terms of acceptance, ease of use and effectiveness in covering the target area.
Objectives of the main Trial :
Primary Objectives: In a double-blind community-based randomized controlled trial among 24,000 children to evaluate the efficacy of application of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life compared to infants cleansed with a similar control solution without Chlorhexidine for:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent resident of Pemba
- •Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff
- •First contact within 48 hours of delivery.
排除标准
- •Congenital malformations where application of intervention is not possible
- •Very sick child needing hospitalization and ICU care.
研究组 & 干预措施
CHX Cord application
Chlorhexidine cord application for 10 days
干预措施: Chlorhexidine 4% (Drug)
Control
Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily
干预措施: Control cord cleaning solution (Other)
结局指标
主要结局
Neonatal Mortality
时间窗: 28 days after birth
次要结局
- Omphalitis(Birth to 28 days of life)