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

• Sponsor: Deborah O'Connor (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04453969
• Collaborator: University of Toronto (Other), Sinai Health System (Other)
• Enrollment: 59
• Locations: 2
• Anticipated Duration (Months): 24.2
• Patients Per Site: 29.5
• Patients Per Site Per Month: 1.2

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. 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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2; Breastmilk	Other: COVID-19

Study Design

• Study Type: Observational
• Actual Enrollment: 59 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
• Actual Study Start Date: May 24, 2020
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Breastfeeding mothers positive for COVID-19	Other: COVID-19; Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy

Outcome Measures

Primary Outcome Measures

1. Presence of SARS-CoV-2 in breastmilk [2-6 months]

   To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19

2. SARS-CoV-2 antibody in breastmilk [2-6 months]

   To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Current COVID-19 positive status or COVID-19 positive status during pregnancy

• Intent to breastfeed or currently breastfeeding

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinai Health System	Toronto	Ontario	Canada	M5G 1X5
2	University of Toronto	Toronto	Ontario	Canada	M5S 1A8

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: NCT04453969
• Other Study ID Numbers: 39373-a
• 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