Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
1 other identifier
observational
59
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2020
CompletedFirst Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2023
CompletedJune 6, 2025
June 1, 2025
2.7 years
June 29, 2020
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Presence of SARS-CoV-2 in breastmilk
To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19
2-6 months
SARS-CoV-2 antibody in breastmilk
To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19
2-6 months
Study Arms (1)
Breastfeeding mothers positive for COVID-19
Interventions
Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy
Eligibility Criteria
Community sample
You may qualify if:
- Current COVID-19 positive status or COVID-19 positive status during pregnancy
- Intent to breastfeed or currently breastfeeding
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deborah O'Connorlead
- University of Torontocollaborator
- Sinai Health Systemcollaborator
Study Sites (2)
Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
University of Toronto
Toronto, Ontario, M5S 1A8, Canada
Related Publications (1)
Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14.
PMID: 38309831BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Scientist
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 1, 2020
Study Start
May 24, 2020
Primary Completion
January 27, 2023
Study Completion
April 27, 2023
Last Updated
June 6, 2025
Record last verified: 2025-06