Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 4:22 PM
Study NCT ID:
NCT04751734
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Maternal COVID-19 Vaccines on Breast Milk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibodies', 'timeFrame': '1st year', 'description': 'presence and levels of antibodies'}], 'secondaryOutcomes': [{'measure': 'breast milk bioactive composition', 'timeFrame': '1st year', 'description': 'immune profile (cytokines and growth factors, immunoglobulins)'}, {'measure': 'breast milk bioactive composition', 'timeFrame': '1st year', 'description': 'microbiota profile'}, {'measure': 'breast milk bioactive composition', 'timeFrame': '1st year', 'description': 'metabolite profile'}, {'measure': 'infant microbiota', 'timeFrame': '1st year', 'description': 'infant microbiota composition and diversity'}, {'measure': 'infant growth and development', 'timeFrame': '1st year', 'description': 'z-scores growth curves'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast milk', 'microbiota', 'metabolites', 'immune compounds', 'growth and development'], 'conditions': ['COVID-19 Vaccines']}, 'referencesModule': {'references': [{'pmid': '35449030', 'type': 'DERIVED', 'citation': 'Selma-Royo M, Bauerl C, Mena-Tudela D, Aguilar-Camprubi L, Perez-Cano FJ, Parra-Llorca A, Lerin C, Martinez-Costa C, Collado MC. Anti-SARS-CoV-2 IgA and IgG in human milk after vaccination is dependent on vaccine type and previous SARS-CoV-2 exposure: a longitudinal study. Genome Med. 2022 Apr 21;14(1):42. doi: 10.1186/s13073-022-01043-9.'}]}, 'descriptionModule': {'briefSummary': 'prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women is Spain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.\n\nExclusion Criteria:\n\n* cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.'}, 'identificationModule': {'nctId': 'NCT04751734', 'acronym': 'MilkCorona', 'briefTitle': 'Impact of Maternal COVID-19 Vaccines on Breast Milk', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Agrochemistry and Food Technology, National Research Council'}, 'officialTitle': 'Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health', 'orgStudyIdInfo': {'id': 'IATA-CSIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinations', 'description': 'SARS-CoV-2 vaccination', 'interventionNames': ['Biological: Covid vaccines']}], 'interventions': [{'name': 'Covid vaccines', 'type': 'BIOLOGICAL', 'description': 'women within Priority groups for coronavirus (COVID-19) vaccination', 'armGroupLabels': ['Vaccinations']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Fundacion Investigacion Sanitaria INCLIVA', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politecnico la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Agrochemistry and Food Technology, National Research Council', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital Clínico Universitario de Valencia', 'class': 'OTHER'}, {'name': 'Hospital Sant Joan de Deu', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, {'name': 'Hospital Universitario Doctor Peset', 'class': 'OTHER'}, {'name': 'Fundacion Para La Investigacion Hospital La Fe', 'class': 'OTHER'}, {'name': 'Universitat Jaume I', 'class': 'OTHER'}, {'name': 'University of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Maria Carmen Collado', 'investigatorAffiliation': 'Institute of Agrochemistry and Food Technology, National Research Council'}}}}