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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breastmilk
• Sars-CoV2

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