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

Covid19 Clinical Trial

— MilkCorona  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768244
• Other study ID #: covid1
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2023
• Source: Institute of Agrochemistry and Food Technology, National Research Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 10, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Spain	Fundacion Investigacion Sanitaria INCLIVA	Valencia
Spain	Hospital Universitario y Politecnico la Fe	Valencia

Sponsors (10)

Lead Sponsor	Collaborator
Institute of Agrochemistry and Food Technology, National Research Council	Fetal Medicine Research Center, Spain, Hospital Clínico Universitario de Valencia, Hospital Sant Joan de Deu, Hospital Universitario Doctor Peset, Hospital Universitario La Fe, INCLIVA, Instituto de Investigación Sanitaria Aragón, Universidad de Granada, Universitat Jaume I

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 RNA	levels of viral RNA from SARS-CoV-2 in breast milk	1 month
Secondary	breast milk immune	interleukines, cytokines and growth factors, immunoglobulins	1st year
Secondary	breast milk microbiota	microbiota composition and diversity	1st year
Secondary	breast milk metabolite	metabolite profile	1st year
Secondary	infant microbiota	infant microbiota profile	1st year
Secondary	infant growth and development	z-scores growth curves	1st year