NCT00497471终止不适用
The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Severe Anemia (PCV < 25%)
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission
详细描述
411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 1 Day 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born in San Francis Designated District Hospital of Ifakara
排除标准
- •Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
- •Birth weight < 1,5 kg
- •Clinical signs of cerebral asphyxia
- •Clinical signs of neonatal or congenital infection
- •Mother unreliable (deaf, mentally handicapped)
结局指标
主要结局
Severe Anemia (PCV < 25%)
时间窗: During first year of life
Clinical Malaria
时间窗: During first year of life
次要结局
- Severe Anemia (PCV < 25%)(After first year of life)
- Outpatient visits
- Severe malaria
- Clinical Malaria(After first year of life)
- Hospital Admissions
研究者
研究点 (1)
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