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

NCT ID: NCT04768244

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-10-10

Brief Summary

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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

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID19

\- Women with SARS-CoV-2 infections

maternal SARS-CoV-2 infection

Intervention Type OTHER

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

Interventions

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maternal SARS-CoV-2 infection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario La Fe

OTHER

Sponsor Role collaborator

Instituto de Investigacion Sanitaria INCLIVA

OTHER

Sponsor Role collaborator

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role collaborator

Hospital Universitario Doctor Peset

OTHER

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role collaborator

Universitat Jaume I

OTHER

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Fetal Medicine Research Center, Spain

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role collaborator

Institute of Agrochemistry and Food Technology, National Research Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maria Carmen Collado

PhD, Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fundacion Investigacion Sanitaria INCLIVA

Valencia, , Spain

Site Status

Hospital Universitario y Politecnico la Fe

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 34417223 (View on PubMed)

Other Identifiers

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covid1

Identifier Type: -

Identifier Source: org_study_id

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