COVID-19 and Lactating Mothers

NCT04558320 | Completed

• 2 other identifiers: STUDY000048893U01AI131344-04S1
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 50 adult lactating parents with COVID-19, and their infants (total sample size = 100). Participants can be residing anywhere in the continental United States.

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• New York University: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 22, 2020
• Study Start: July 2, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Locations

US (1)