Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
MilkCorona
Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
1 other identifier
observational
100
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedOctober 25, 2023
October 1, 2023
3 years
February 10, 2021
October 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SARS-CoV-2 RNA
levels of viral RNA from SARS-CoV-2 in breast milk
1 month
Secondary Outcomes (5)
breast milk immune
1st year
breast milk microbiota
1st year
breast milk metabolite
1st year
infant microbiota
1st year
infant growth and development
1st year
Study Arms (1)
COVID19
\- Women with SARS-CoV-2 infections
Interventions
positive PCR in nasopharinx and/or presence of antibodies in serum
Eligibility Criteria
Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.
You may qualify if:
- 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
You may not qualify if:
- aggravation of symptomatology requiring specific treatment and/or hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Agrochemistry and Food Technology, National Research Councillead
- Hospital Universitario La Fecollaborator
- Instituto de Investigacion Sanitaria INCLIVAcollaborator
- Hospital Clínico Universitario de Valenciacollaborator
- Hospital Universitario Doctor Pesetcollaborator
- Universidad de Granadacollaborator
- Universitat Jaume Icollaborator
- Hospital Sant Joan de Deucollaborator
- Fetal Medicine Research Center, Spaincollaborator
- Instituto de Investigación Sanitaria Aragóncollaborator
Study Sites (2)
Fundacion Investigacion Sanitaria INCLIVA
Valencia, Spain
Hospital Universitario y Politecnico la Fe
Valencia, Spain
Related Publications (1)
Bauerl C, Randazzo W, Sanchez G, Selma-Royo M, Garcia Verdevio E, Martinez L, Parra-Llorca A, Lerin C, Fumado V, Crovetto F, Crispi F, Perez-Cano FJ, Rodriguez G, Ruiz-Redondo G, Campoy C, Martinez-Costa C, Collado MC; MilkCORONA study team. SARS-CoV-2 RNA and antibody detection in breast milk from a prospective multicentre study in Spain. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):216-221. doi: 10.1136/archdischild-2021-322463. Epub 2021 Aug 20.
PMID: 34417223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Research Scientist
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 24, 2021
Study Start
April 1, 2020
Primary Completion
March 31, 2023
Study Completion
October 10, 2023
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share