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NCT04453982 Clinical Trial

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

Sars-CoV2 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04453982
Other study ID # 39373-b
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 21, 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 384
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: - Human milk donor for the Rogers Hixon Ontario Human Milk Bank Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Human milk donors
Human milk donors for the Rogers Hixon Ontario Human Milk Bank

Locations
Country Name City State
Canada Sinai Health System 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 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
Primary 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
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