Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
1 other identifier
observational
384
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
1 active site
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
June 21, 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
April 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2023
CompletedJune 6, 2025
June 1, 2025
2.8 years
June 29, 2020
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Prevalence of SARS-CoV-2 in breastmilk
To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2
2 months
Prevalence of SARS-CoV-2 antibody in breastmilk
To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2
2 months
Study Arms (1)
Human milk donors
Interventions
Human milk donors for the Rogers Hixon Ontario Human Milk Bank
Eligibility Criteria
Community sample
You may qualify if:
- \- Human milk donor for the Rogers Hixon Ontario Human Milk Bank
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 (1)
Sinai Health System
Toronto, Ontario, M5G 1X5, 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
June 21, 2020
Primary Completion
April 27, 2023
Study Completion
April 27, 2023
Last Updated
June 6, 2025
Record last verified: 2025-06