Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT04453969
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2020-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of SARS-CoV-2 in breastmilk', 'timeFrame': '2-6 months', 'description': 'To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19'}, {'measure': 'SARS-CoV-2 antibody in breastmilk', 'timeFrame': '2-6 months', 'description': 'To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV2', 'Breastmilk']}, 'referencesModule': {'references': [{'pmid': '38309831', 'type': 'BACKGROUND', 'citation': "Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current COVID-19 positive status or COVID-19 positive status during pregnancy\n* Intent to breastfeed or currently breastfeeding\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT04453969', 'briefTitle': 'Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a', 'orgStudyIdInfo': {'id': '39373-a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breastfeeding mothers positive for COVID-19', 'interventionNames': ['Other: COVID-19']}], 'interventions': [{'name': 'COVID-19', 'type': 'OTHER', 'description': 'Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy', 'armGroupLabels': ['Breastfeeding mothers positive for COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sinai Health System', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 1A8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Deborah O'Connor", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Sinai Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Scientist', 'investigatorFullName': "Deborah O'Connor", 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}