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)


Lead Sponsor: Institute of Agrochemistry and Food Technology, National Research Council

Collaborator: Hospital Universitario La Fe
Hospital Clínico Universitario de Valencia
Hospital Universitario Doctor Peset
Universidad de Granada
Universitat Jaume I
Hospital Sant Joan de Deu
Fetal Medicine Research Center, Spain
Instituto de Investigación Sanitaria Aragón

Source 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

Overall Status Recruiting
Start Date 2020-04-01
Completion Date 2021-12-01
Primary Completion Date 2021-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
SARS-CoV-2 RNA 1 month
Secondary Outcome
Measure Time Frame
breast milk immune 1st year
breast milk microbiota 1st year
breast milk metabolite 1st year
infant microbiota 1st year
infant growth and development 1st year
Enrollment 100

Intervention Type: Other

Intervention Name: maternal SARS-CoV-2 infection

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

Arm Group Label: COVID19


Sampling Method:

Non-Probability Sample


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



Gender Based:


Gender Description:

Pregnant women at the end of the pregnancy and also, lactating women

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Facility: Status: Contact:
Fundacion Investigacion Sanitaria INCLIVA | Valencia, Spain Recruiting Cecilia Martinez-Costa, MD, PhD +34 961973913 [email protected]
Hospital Universitario y Politecnico la Fe | Valencia, Spain Enrolling by invitation
Location Countries


Verification Date


Responsible Party

Type: Principal Investigator

Investigator Affiliation: Institute of Agrochemistry and Food Technology, National Research Council

Investigator Full Name: Maria Carmen Collado

Investigator Title: PhD, Research Scientist

Has Expanded Access No
Arm Group

Label: COVID19

Description: - Women with SARS-CoV-2 infections

Acronym MilkCorona
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

This information was retrieved directly from the website without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on, this will be updated automatically on our website as well.

Clinical Research News