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

NCT ID: NCT04453969

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-24

Study Completion Date

2023-04-27

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV2 Breastmilk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breastfeeding mothers positive for COVID-19

COVID-19

Intervention Type OTHER

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

Interventions

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COVID-19

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Sinai Health System

OTHER

Sponsor Role collaborator

Deborah O'Connor

OTHER

Sponsor Role lead

Responsible Party

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Deborah O'Connor

Scientist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sinai Health System

Toronto, Ontario, Canada

Site Status

University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 38309831 (View on PubMed)

Other Identifiers

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39373-a

Identifier Type: -

Identifier Source: org_study_id

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