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OpenTrials
Completed

NCT Number: NCT04751734

Impact of Maternal COVID-19 Vaccines on Breast Milk

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

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Key information

Conditions

COVID-19 Vaccines

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Fundacion Investigacion Sanitaria INCLIVA, Valencia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Covid vaccines

Biological

women within Priority groups for coronavirus (COVID-19) vaccination

Primary outcomes

  1. Antibodies

    Time frame: 1st year

    presence and levels of antibodies

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: MilkCorona

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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