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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04453969
Enrollment
59
Registered
2020-07-01
Start date
2020-05-24
Completion date
2023-04-27
Last updated
2025-06-06

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

Conditions

Breastmilk, SARS-CoV2

Brief summary

The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.

Interventions

OTHERCOVID-19

Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy

Sponsors

University of Toronto
CollaboratorOTHER
Sinai Health System
CollaboratorOTHER
Deborah O'Connor
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Current COVID-19 positive status or COVID-19 positive status during pregnancy * Intent to breastfeed or currently breastfeeding

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Presence of SARS-CoV-2 in breastmilk2-6 monthsTo describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19
SARS-CoV-2 antibody in breastmilk2-6 monthsTo describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026