SARS-CoV2NCT04453969
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
An observational study of SARS-CoV2 and Breastmilk, run by Deborah O'Connor at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2, Breastmilk
- What is being tested?
- COVID-19
- How many people
- 59 participants
- Where
- 2 sitesCanada
- Study dates
- 24 May 2020to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community sample
Who may be able to join
- Current COVID-19 positive status or COVID-19 positive status during pregnancy
- Intent to breastfeed or currently breastfeeding
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sinai Health System
Toronto, Ontario, M5G 1X5
University of Toronto
Toronto, Ontario, M5S 1A8
About this study
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.
- Conditions
- SARS-CoV2, Breastmilk
- Being tested
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding mothers positive for COVID-19 | Not described Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start24 May 2020
- Primary completion27 Jan 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah O'Connor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Sinai Health System
- Responsible party
- Sponsor-investigator, Deborah O'Connor, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453969
- Sponsor's protocol ID
- 39373-a
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2020
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38309831
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
- ClinicalTrials.gov ID
- NCT04453969
- Acronym / sponsor ID
- 39373-a
- Conditions
- SARS-CoV2, Breastmilk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Deborah O'ConnorUniversity, hospital or other
- Collaborators
- University of Toronto, Sinai Health System
- Study start
- 24 May 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding mothers positive for COVID-19 | – | Other: COVID-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Current COVID-19 positive status or COVID-19 positive status during pregnancy
- Intent to breastfeed or currently breastfeeding
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy | Other | Breastfeeding mothers positive for COVID-19 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 38309831Ismail 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 and Breastmilk, run by Deborah O'Connor at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of SARS-CoV-2 in breastmilk (time frame: 2-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.