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OpenTrials
Completed

NCT Number: NCT04558320

COVID-19 and Lactating Mothers

The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Child:
  • 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

Exclusion criteria

  • Non-English speaking

Treatment and study plan

Primary outcomes

  1. mean change in SARS-Cov-2 viral load in breast milk

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • New York University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2020
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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