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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768244
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : March 29, 2022
Sponsor:
Collaborators:
Hospital Universitario La Fe
INCLIVA
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
Information provided by (Responsible Party):
Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

Study Description
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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

Condition or disease Intervention/treatment
Covid19 Other: maternal SARS-CoV-2 infection

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. SARS-CoV-2 RNA [ Time Frame: 1 month ]
    levels of viral RNA from SARS-CoV-2 in breast milk


Secondary Outcome Measures :
  1. breast milk immune [ Time Frame: 1st year ]
    interleukines, cytokines and growth factors, immunoglobulins

  2. breast milk microbiota [ Time Frame: 1st year ]
    microbiota composition and diversity

  3. breast milk metabolite [ Time Frame: 1st year ]
    metabolite profile

  4. infant microbiota [ Time Frame: 1st year ]
    infant microbiota profile

  5. infant growth and development [ Time Frame: 1st year ]
    z-scores growth curves


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women at the end of the pregnancy and also, lactating women
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768244


Locations
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Spain
Fundacion Investigacion Sanitaria INCLIVA Recruiting
Valencia, Spain
Contact: Cecilia Martinez-Costa, MD, PhD    +34 961973913    Cecilia.Martinez@uv.es   
Hospital Universitario y Politecnico la Fe Enrolling by invitation
Valencia, Spain
Sponsors and Collaborators
Institute of Agrochemistry and Food Technology, National Research Council
Hospital Universitario La Fe
INCLIVA
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
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maria Carmen Collado, PhD, Research Scientist, Institute of Agrochemistry and Food Technology, National Research Council
ClinicalTrials.gov Identifier: NCT04768244    
Other Study ID Numbers: covid1
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council:
Breast milk
Microbiota
Sars-CoV-2
 metabolites
immune compounds
infant growth and development
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases