NCT00197652已完成不适用
Botswana Diarrheal Diseases Study
Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2001年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,350
- 试验地点
- 1
- 主要终点
- OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
研究概览
简要总结
The goals of this study are to:
- determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.
- analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
- comparison to rates among infants born to HIV uninfected mothers.
- link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide independent informed consent.
- •Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
- •Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.
- •For HIV-infected subjects:
- •Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.
排除标准
- •Subject cannot provide legal independent informed consent.
结局指标
主要结局
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
时间窗: 24 months
次要结局
未报告次要终点
研究者
Roger Shapiro
Principal Investigator
Harvard School of Public Health (HSPH)
研究点 (1)
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