Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
Completed
- Conditions
- Covid19
- Registration Number
- NCT04768244
- 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 on breast milk immune, microbiological, and metabolic profile and infant growth and development
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals
Exclusion Criteria
- aggravation of symptomatology requiring specific treatment and/or hospitalization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SARS-CoV-2 RNA 1 month levels of viral RNA from SARS-CoV-2 in breast milk
- Secondary Outcome Measures
Name Time Method breast milk metabolite 1st year metabolite profile
breast milk microbiota 1st year microbiota composition and diversity
infant microbiota 1st year infant microbiota profile
infant growth and development 1st year z-scores growth curves
breast milk immune 1st year interleukines, cytokines and growth factors, immunoglobulins
Trial Locations
- Locations (2)
Fundacion Investigacion Sanitaria INCLIVA
🇪🇸Valencia, Spain
Hospital Universitario y Politecnico la Fe
🇪🇸Valencia, Spain
Fundacion Investigacion Sanitaria INCLIVA🇪🇸Valencia, Spain