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

NCT04768244 — Completed, 100 participants, Institute of Agrochemistry and Food Technology, National Research Council

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

Registry	NCT04768244, acronym MilkCorona
Status	Completed
Study type	Observational
Enrollment	100 (Actual)
Sponsor	Institute of Agrochemistry and Food Technology, National Research Council (Other gov); collaborators: Hospital Universitario La Fe, Instituto de Investigacion Sanitaria 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
Conditions	Covid19
Interventions	maternal SARS-CoV-2 infection (Other)
Dates	start 2020-04-01, primary completion 2023-03-31, completion 2023-10-10, first posted 2021-02-24, last updated 2023-10-25
Locations	2 sites in Spain

-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

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+Arms and interventions

Arm	Type	Interventions	Description
COVID19		Other: maternal SARS-CoV-2 infection	\- Women with SARS-CoV-2 infections

maternal SARS-CoV-2 infection (Other): positive PCR in nasopharinx and/or presence of antibodies in serum

+Outcome measures

Primary outcomes

SARS-CoV-2 RNA [1 month]: levels of viral RNA from SARS-CoV-2 in breast milk

Secondary outcomes

breast milk immune [1st year]: interleukines, cytokines and growth factors, immunoglobulins
breast milk microbiota [1st year]: microbiota composition and diversity
breast milk metabolite [1st year]: metabolite profile
infant microbiota [1st year]: infant microbiota profile
infant growth and development [1st year]: z-scores growth curves

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Fundacion Investigacion Sanitaria INCLIVA	Valencia	Spain
Hospital Universitario y Politecnico la Fe	Valencia	Spain

+Publications

Results publication: 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 34417223