Impact of Maternal COVID-19 Vaccines on Breast Milk (MilkCorona)

March 15, 2024 updated by: Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health

prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Fundacion Investigacion Sanitaria INCLIVA
      • Valencia, Spain
        • Hospital Universitario y Politécnico La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women is Spain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinations
SARS-CoV-2 vaccination
Biological: Covid vaccines
women within Priority groups for coronavirus (COVID-19) vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibodies
Time Frame: 1st year
presence and levels of antibodies
1st year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast milk bioactive composition
Time Frame: 1st year
immune profile (cytokines and growth factors, immunoglobulins)
1st year
breast milk bioactive composition
Time Frame: 1st year
microbiota profile
1st year
breast milk bioactive composition
Time Frame: 1st year
metabolite profile
1st year
infant microbiota
Time Frame: 1st year
infant microbiota composition and diversity
1st year
infant growth and development
Time Frame: 1st year
z-scores growth curves
1st year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Collaborators

Universitat Jaume I
Hospital Universitario La Fe
University of Barcelona
Hospital Universitario Doctor Peset
Fundacion Para La Investigacion Hospital La Fe
Hospital Sant Joan de Deu
Hospital Clínico Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IATA-CSIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

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