Impact of Maternal COVID-19 Vaccines on Breast Milk
Completed
- Conditions
- COVID-19 Vaccines
- Registration Number
- NCT04751734
- Lead Sponsor
- Institute of Agrochemistry and Food Technology, National Research Council
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibodies 1st year presence and levels of antibodies
- Secondary Outcome Measures
Name Time Method infant microbiota 1st year infant microbiota composition and diversity
infant growth and development 1st year z-scores growth curves
breast milk bioactive composition 1st year metabolite profile
Trial Locations
- Locations (2)
Fundacion Investigacion Sanitaria INCLIVA
🇪🇸Valencia, Spain
Hospital Universitario y Politecnico la Fe
🇪🇸Valencia, Spain
Fundacion Investigacion Sanitaria INCLIVA🇪🇸Valencia, Spain