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OpenTrials
Completed

NCT Number: NCT04453982

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

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. When mothers of hospitalized infants are unable to supply their milk, the recommended supplement is human donor milk. The impact of a pandemic on human milk banking is unknown. This study seeks to address this public health issue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System in Toronto. 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 donor milk banking 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, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Human milk donor for the Rogers Hixon Ontario Human Milk Bank

Exclusion criteria

  • None

Treatment and study plan

Human milk donors

Other

Human milk donors for the Rogers Hixon Ontario Human Milk Bank

Primary outcomes

  1. Prevalence of SARS-CoV-2 in breastmilk

    Time frame: 2 months

    To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2

  2. Prevalence of SARS-CoV-2 antibody in breastmilk

    Time frame: 2 months

    To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2

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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