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

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

Sponsors

Lead Sponsor: Institute of Agrochemistry and Food Technology, National Research Council

Collaborator: Hospital Universitario La Fe
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

Source Institute of Agrochemistry and Food Technology, National Research Council
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

Overall Status Recruiting
Start Date 2020-04-01
Completion Date 2021-12-01
Primary Completion Date 2021-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
SARS-CoV-2 RNA 1 month
Secondary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: maternal SARS-CoV-2 infection

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

Arm Group Label: COVID19

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Female

Gender Based:

Yes

Gender Description:

Pregnant women at the end of the pregnancy and also, lactating women

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Location
Facility: Status: Contact:
Fundacion Investigacion Sanitaria INCLIVA | Valencia, Spain Recruiting Cecilia Martinez-Costa, MD, PhD +34 961973913 [email protected]
Hospital Universitario y Politecnico la Fe | Valencia, Spain Enrolling by invitation
Location Countries

Spain

Verification Date

2021-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Institute of Agrochemistry and Food Technology, National Research Council

Investigator Full Name: Maria Carmen Collado

Investigator Title: PhD, Research Scientist

Keywords
Has Expanded Access No
Arm Group

Label: COVID19

Description: - Women with SARS-CoV-2 infections

Acronym MilkCorona
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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