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OpenTrials
Completed

NCT Number: NCT04453969

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

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.

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Key information

Conditions

Sars-CoV2 Breastmilk

Sex eligibility

All sexes

Study type

Observational

Primary location

Sinai Health System, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

COVID-19

Other

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

Primary outcomes

  1. Presence of SARS-CoV-2 in breastmilk

    Time frame: 2-6 months

    To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19

  2. SARS-CoV-2 antibody in breastmilk

    Time frame: 2-6 months

    To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19

Sponsors and collaborators

Lead sponsor

Deborah O'Connor

Other

Collaborators

  • Sinai Health System
  • University of Toronto

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2020
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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