Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77,535
- 试验地点
- 1
- 主要终点
- All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
研究概览
简要总结
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.
详细描述
The primary goals of the Zambia Chlorhexidine Application Trial (ZamCAT) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in Southern Province, Zambia. Secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants.
Clusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. In the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. Mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
In order to achieve the 4th Millennium Development Goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. If the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in Zambia. These results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-Saharan Africa.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in the 2nd or 3rd trimester
- •Age 15 years and above
- •Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
- •Willingness to provide cord care as per the protocol of their cluster
- •Willingness to provide informed consent
排除标准
- •Pregnant women who are not willing to provide cord care as per the protocol of their cluster
- •Pregnant women who are not willing to provide informed consent
- •Pregnant women in the 1st trimester
- •Pregnant women under age 15 years
研究组 & 干预措施
Dry cord care
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
干预措施: Dry cord care (Procedure)
Chlorhexidine cord care
Mothers located in health facility catchment areas assigned to this arm will apply Chlorhexidine gluconate (4%) to their infants daily until three days after the cord completely separates. Bottles of chlorhexidine is provided to women during antenatal care.
干预措施: Chlorhexidine gluconate (4%) (Drug)
结局指标
主要结局
All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
时间窗: 28 days post-partum
All-cause mortality by day 28 of life among newborns who survive at least the first day of life
All-cause Neonatal Mortality
时间窗: 28 days post-partum
All-cause neonatal mortality based on vital status at 28 days post-partum
次要结局
- Place of Delivery(28 days postpartum)
- Health Facility Characteristics(12 months after study initiation)
- Incidence of Omphalitis(28 days postpartum)
- Factors Influencing Delivery Location(28 days postpartum)