Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04558320
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2020-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 and Lactating Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2020-09-19', 'studyFirstSubmitQcDate': '2020-09-19', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean change in SARS-Cov-2 viral load in breast milk', 'timeFrame': 'baseline, days 3, 10, 19, 28 and 90', 'description': 'RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include 50 adult lactating parents with COVID-19, and their infants (total sample size = 100). Participants can be residing anywhere in the continental United States.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently lactating mother:\n\n * English-speaking\n * greater than or equal to 18 years of age\n * Assigned female at birth (AFAB)\n * Having a positive COVID-19 test within 14 days\n* Child:\n\n * Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included\n\nExclusion Criteria:\n\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT04558320', 'briefTitle': 'COVID-19 and Lactating Mothers', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'COVID-19 and Lactating Mothers', 'orgStudyIdInfo': {'id': 'STUDY00004889'}, 'secondaryIdInfos': [{'id': '3U01AI131344-04S1', 'link': 'https://reporter.nih.gov/quickSearch/3U01AI131344-04S1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'New York University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kirsi Jarvinen-Seppo', 'investigatorAffiliation': 'University of Rochester'}}}}