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NCT04558320 Clinical Trial

COVID-19 and Lactating Mothers

Coronavirus Infection Clinical Trial

Official title:
COVID-19 and Lactating Mothers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04558320
Other study ID # STUDY00004889
Secondary ID 3U01AI131344-04S
Status Completed
Phase
First received
Last updated
Start date July 2, 2020
Est. completion date September 1, 2021

Study information
Verified date November 2021
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date September 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (3)
Lead Sponsor Collaborator
University of Rochester National Institute of Allergy and Infectious Diseases (NIAID), New York University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean change in SARS-Cov-2 viral load in breast milk 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. baseline, days 3, 10, 19, 28 and 90
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