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临床试验/NCT05004740
NCT05004740已完成不适用

Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Deborah O'Connor1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination

研究概览

简要总结

This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • lactating birthing persons from the general public or Sinai Health System

排除标准

  • 未提供

结局指标

主要结局

Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination

时间窗: Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deborah O'Connor

Scientist

The Hospital for Sick Children

研究点 (1)

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