Lufwanyama Neonatal Survival Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,559
- 主要终点
- mortality
研究概览
简要总结
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.
详细描述
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TBA trained in safe delivery;
- •willing to sign informed consent; willing to be randomized; willing to adhere to study procedures
排除标准
- •TBA living outside of Lufwanyama district
结局指标
主要结局
mortality
时间窗: day 28
次要结局
- perinatal mortality(day zero)
- sepsis mortality(deaths between days 1-28)
- cost effectiveness(days 0-28)
- successful delivery of nevirapine prophylaxis to HIV exposed deliveries(day zero umbilical cord dried blood spot)