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

Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04768244
Acronym
MilkCorona
Enrollment
100
Registered
2021-02-24
Start date
2020-04-01
Completion date
2023-10-10
Last updated
2023-10-25

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

Conditions

Covid19

Keywords

Breast milk, Microbiota, Sars-CoV-2, metabolites, immune compounds, infant growth and development

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

Interventions

OTHERmaternal SARS-CoV-2 infection

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

Sponsors

Hospital Universitario La Fe
CollaboratorOTHER
Instituto de Investigacion Sanitaria INCLIVA
CollaboratorOTHER
Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Hospital Universitario Doctor Peset
CollaboratorOTHER
Universidad de Granada
CollaboratorOTHER
Universitat Jaume I
CollaboratorOTHER
Hospital Sant Joan de Deu
CollaboratorOTHER
Fetal Medicine Research Center, Spain
CollaboratorOTHER
Instituto de Investigación Sanitaria Aragón
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 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2 RNA1 monthlevels of viral RNA from SARS-CoV-2 in breast milk

Secondary

MeasureTime frameDescription
breast milk immune1st yearinterleukines, cytokines and growth factors, immunoglobulins
breast milk microbiota1st yearmicrobiota composition and diversity
breast milk metabolite1st yearmetabolite profile
infant microbiota1st yearinfant microbiota profile
infant growth and development1st yearz-scores growth curves

Countries

Spain

Outcome results

None listed

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