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NCT04751734 Clinical Trial

Impact of Maternal COVID-19 Vaccines on Breast Milk

COVID-19 Vaccines Clinical Trial

— MilkCorona  

Official title:
Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04751734
Other study ID # IATA-CSIC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2021
Est. completion date December 31, 2023

Study information
Verified date March 2024
Source Institute of Agrochemistry and Food Technology, National Research Council
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines. Exclusion Criteria: - cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Covid vaccines
women within Priority groups for coronavirus (COVID-19) vaccination

Locations
Country Name City State
Spain Fundacion Investigacion Sanitaria INCLIVA Valencia
Spain Hospital Universitario y Politecnico la Fe Valencia

Sponsors (8)
Lead Sponsor Collaborator
Institute of Agrochemistry and Food Technology, National Research Council Fundacion Para La Investigacion Hospital La Fe, Hospital Clínico Universitario de Valencia, Hospital Sant Joan de Deu, Hospital Universitario Doctor Peset, Hospital Universitario La Fe, Universitat Jaume I, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antibodies presence and levels of antibodies 1st year
Secondary breast milk bioactive composition immune profile (cytokines and growth factors, immunoglobulins) 1st year
Secondary breast milk bioactive composition microbiota profile 1st year
Secondary breast milk bioactive composition metabolite profile 1st year
Secondary infant microbiota infant microbiota composition and diversity 1st year
Secondary infant growth and development z-scores growth curves 1st year
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