Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Deborah O'Connor

Status: Active, not recruiting

Conditions: COVID-19 Vaccine; Breastmilk

Treatments: Other: Vaccinated Pregnant or Lactating persons

Study type: Observational

Funder types: Other

Identifiers

NCT05004740

39373-c

Details and patient eligibility

About

This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.

Enrollment: 78 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• lactating birthing persons from the general public or Sinai Health System

Exclusion criteria

• None

Trial design

78 participants in 1 patient group

Lactating birthing persons delivering at Sinai Health System or from the general population

Treatment:

Other: Vaccinated Pregnant or Lactating persons