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

• Sponsor: Deborah O'Connor (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04453982
• Collaborator: University of Toronto (Other), Sinai Health System (Other)
• Enrollment: 384
• Location: 1
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 16.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2; Breastmilk	Other: Human milk donors

Study Design

• Study Type: Observational
• Actual Enrollment: 384 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
• Actual Study Start Date: Jun 21, 2020
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Human milk donors	Other: Human milk donors; Human milk donors for the Rogers Hixon Ontario Human Milk Bank

Outcome Measures

Primary Outcome Measures

1. Prevalence of SARS-CoV-2 in breastmilk [2 months]

   To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2

2. Prevalence of SARS-CoV-2 antibody in breastmilk [2 months]

   To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Human milk donor for the Rogers Hixon Ontario Human Milk Bank

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinai Health System	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

• Deborah O'Connor
• University of Toronto
• Sinai Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah O'Connor, Scientist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT04453982
• Other Study ID Numbers: 39373-b
• First Posted: Jul 1, 2020
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 13, 2022