COVID-19 and Lactating Mothers

Completed

• Conditions: Coronavirus Infection

• Registration Number: NCT04558320
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-22
• Primary Completion: 2021-04-01
• Study Completion: 2021-09-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean change in SARS-Cov-2 viral load in breast milk	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States