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Impact of Maternal COVID-19 Vaccines on Breast Milk

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04751734
Acronym
MilkCorona
Enrollment
120
Registered
2021-02-12
Start date
2021-01-16
Completion date
2023-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccines

Keywords

breast milk, microbiota, metabolites, immune compounds, growth and development

Brief 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.

Interventions

BIOLOGICALCovid vaccines

women within Priority groups for coronavirus (COVID-19) vaccination

Sponsors

Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Hospital Sant Joan de Deu
CollaboratorOTHER
Hospital Universitario La Fe
CollaboratorOTHER
Hospital Universitario Doctor Peset
CollaboratorOTHER
Fundacion Para La Investigacion Hospital La Fe
CollaboratorOTHER
Universitat Jaume I
CollaboratorOTHER
University of Barcelona
CollaboratorOTHER
Institute of Agrochemistry and Food Technology, National Research Council
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Antibodies1st yearpresence and levels of antibodies

Secondary

MeasureTime frameDescription
breast milk bioactive composition1st yearimmune profile (cytokines and growth factors, immunoglobulins)
infant microbiota1st yearinfant microbiota composition and diversity
infant growth and development1st yearz-scores growth curves

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026