Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health

Institute of Agrochemistry and Food Technology, National Research Council100 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Covid19

Interventions

maternal SARS-CoV-2 infectionOTHER

positive PCR in nasopharinx and/or presence of antibodies in serum

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Fundacion Investigacion Sanitaria INCLIVA

Valencia, Spain

Hospital Universitario y Politecnico la Fe

Valencia, Spain

Outcomes

Primary Outcomes

SARS-CoV-2 RNA

levels of viral RNA from SARS-CoV-2 in breast milk

Time frame: 1 month

Secondary Outcomes

breast milk immune

interleukines, cytokines and growth factors, immunoglobulins

Time frame: 1st year

breast milk microbiota

microbiota composition and diversity

Time frame: 1st year

breast milk metabolite

metabolite profile

Time frame: 1st year

infant microbiota

infant microbiota profile

Time frame: 1st year

infant growth and development

z-scores growth curves

Time frame: 1st year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.