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OpenTrials
Completed

NCT Number: NCT04768244

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fundacion Investigacion Sanitaria INCLIVA, Valencia, Spain

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

maternal SARS-CoV-2 infection

Other

positive PCR in nasopharinx and/or presence of antibodies in serum

Primary outcomes

  1. SARS-CoV-2 RNA

    Time frame: 1 month

    levels of viral RNA from SARS-CoV-2 in breast milk

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Other Gov

Collaborators

  • Fetal Medicine Research Center, Spain
  • Hospital Clínico Universitario de Valencia
  • Hospital Sant Joan de Deu
  • Hospital Universitario Doctor Peset
  • Hospital Universitario La Fe
  • Instituto de Investigacion Sanitaria INCLIVA
  • Instituto de Investigación Sanitaria Aragón
  • Universidad de Granada
  • Universitat Jaume I

Registry information

Official study title

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

Acronym: MilkCorona

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2021
Registry last updated
Oct 25, 2023

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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