Impact of Maternal COVID-19 Vaccines on Breast Milk

Institute of Agrochemistry and Food Technology, National Research Council120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

COVID-19 Vaccines

Interventions

Covid vaccinesBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Fundacion Investigacion Sanitaria INCLIVA

Valencia, Spain

Hospital Universitario y Politecnico la Fe

Valencia, Spain

Outcomes

Primary Outcomes

Antibodies

presence and levels of antibodies

Time frame: 1st year

Secondary Outcomes

breast milk bioactive composition

immune profile (cytokines and growth factors, immunoglobulins)

Time frame: 1st year

breast milk bioactive composition

microbiota profile

Time frame: 1st year

breast milk bioactive composition

metabolite profile

Time frame: 1st year

infant microbiota

infant microbiota composition and diversity

Time frame: 1st year

infant growth and development

z-scores growth curves

Time frame: 1st year

Data from ClinicalTrials.gov

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