COVID-19 and Lactating Mothers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04558320

Enrollment

Registered

2020-09-22

Start date

2020-07-02

Completion date

2021-09-01

Last updated

2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results