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

October 24, 2023 updated by: Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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 to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID19
- Women with SARS-CoV-2 infections
Other: maternal SARS-CoV-2 infection
positive PCR in nasopharinx and/or presence of antibodies in serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 RNA
Time Frame: 1 month
levels of viral RNA from SARS-CoV-2 in breast milk
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infant growth and development
Time Frame: 1st year
z-scores growth curves
1st year
breast milk immune
Time Frame: 1st year
interleukines, cytokines and growth factors, immunoglobulins
1st year
breast milk microbiota
Time Frame: 1st year
microbiota composition and diversity
1st year
breast milk metabolite
Time Frame: 1st year
metabolite profile
1st year
infant microbiota
Time Frame: 1st year
infant microbiota profile
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
INCLIVA
Universidad de Granada
Hospital Universitario La Fe
Fetal Medicine Research Center, Spain
Hospital Universitario Doctor Peset
Hospital Sant Joan de Deu
Instituto de Investigación Sanitaria Aragón
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)

April 1, 2020

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • covid1

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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