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NCT04453969 Clinical Trial

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

SARS-CoV2 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04453969
Other study ID # 39373-a
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 24, 2020
Est. completion date April 27, 2023

Study information
Verified date October 2022
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 59
Est. completion date April 27, 2023
Est. primary completion date April 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Current COVID-19 positive status or COVID-19 positive status during pregnancy - Intent to breastfeed or currently breastfeeding Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Sinai Health System Toronto Ontario
Canada University of Toronto Toronto Ontario

Sponsors (3)
Lead Sponsor Collaborator
Deborah O'Connor Sinai Health System, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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