NCT04768244已完成不适用
Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
Institute of Agrochemistry and Food Technology, National Research Council2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 RNA
研究概览
简要总结
prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals
排除标准
- •aggravation of symptomatology requiring specific treatment and/or hospitalization
结局指标
主要结局
SARS-CoV-2 RNA
时间窗: 1 month
levels of viral RNA from SARS-CoV-2 in breast milk
次要结局
- infant growth and development(1st year)
- breast milk metabolite(1st year)
- infant microbiota(1st year)
- breast milk immune(1st year)
- breast milk microbiota(1st year)
研究者
Maria Carmen Collado
PhD, Research Scientist
Institute of Agrochemistry and Food Technology, National Research Council
研究点 (2)
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