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

NCT ID: NCT04453982

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

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-21

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. 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.

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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Human milk donors

Human milk donors

Intervention Type OTHER

Human milk donors for the Rogers Hixon Ontario Human Milk Bank

Interventions

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Human milk donors

Human milk donors for the Rogers Hixon Ontario Human Milk Bank

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Human milk donor for the Rogers Hixon Ontario Human Milk Bank

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

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-b

Identifier Type: -

Identifier Source: org_study_id

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