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

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ClinicalTrials.gov Identifier: NCT04751734
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2021
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Hospital Clínico Universitario de Valencia
Hospital Sant Joan de Deu
Hospital Universitario La Fe
Hospital Universitario Doctor Peset
Fundacion Para La Investigacion Hospital La Fe
Universitat Jaume I
University of Barcelona
Information provided by (Responsible Party):
Maria Carmen Collado, 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 vaccination on breast milk immune, microbiological, and metabolic profile.

Condition or disease Intervention/treatment
COVID-19 Vaccines Biological: Covid vaccines

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health
Actual Study Start Date : January 16, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Antibodies [ Time Frame: 1st year ]
    presence and levels of antibodies


Secondary Outcome Measures :
  1. breast milk bioactive composition [ Time Frame: 1st year ]
    immune profile (cytokines and growth factors, immunoglobulins)

  2. breast milk bioactive composition [ Time Frame: 1st year ]
    microbiota profile

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

  4. infant microbiota [ Time Frame: 1st year ]
    infant microbiota composition and diversity

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women is Spain
Criteria

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.

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): NCT04751734


Locations
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Spain
Fundacion Investigacion Sanitaria INCLIVA
Valencia, Spain
Hospital Universitario y Politecnico la Fe
Valencia, Spain
Sponsors and Collaborators
Institute of Agrochemistry and Food Technology, National Research Council
Hospital Clínico Universitario de Valencia
Hospital Sant Joan de Deu
Hospital Universitario La Fe
Hospital Universitario Doctor Peset
Fundacion Para La Investigacion Hospital La Fe
Universitat Jaume I
University of Barcelona
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Responsible Party: Maria Carmen Collado, Researcher, Institute of Agrochemistry and Food Technology, National Research Council
ClinicalTrials.gov Identifier: NCT04751734    
Other Study ID Numbers: IATA-CSIC
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
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
metabolites
immune compounds
growth and development