COVID-19 and Lactating Mothers

University of Rochester1 site in 1 country76 target enrollmentJuly 2, 2020

ConditionsCoronavirus Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronavirus Infection
Sponsor: University of Rochester
Enrollment: 76
Locations: 1
Primary Endpoint: mean change in SARS-Cov-2 viral load in breast milk
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2, 2020

End Date

September 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Kirsi Jarvinen-Seppo

Associate Professor

University of Rochester

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

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.