NCT04558320已完成不适用
COVID-19 and Lactating Mothers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- mean change in SARS-Cov-2 viral load in breast milk
研究概览
简要总结
The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.
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
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently lactating mother:
- •English-speaking
- •greater than or equal to 18 years of age
- •Assigned female at birth (AFAB)
- •Having a positive COVID-19 test within 14 days
- •Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included
排除标准
- •Non-English speaking
结局指标
主要结局
mean change in SARS-Cov-2 viral load in breast milk
时间窗: baseline, days 3, 10, 19, 28 and 90
RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms.
次要结局
未报告次要终点
研究者
Kirsi Jarvinen-Seppo
Associate Professor
University of Rochester
研究点 (1)
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