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

Completed

• Conditions: Covid19
• Interventions: Other: maternal SARS-CoV-2 infection

• Registration Number: NCT04768244
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-24
• Primary Completion: 2023-03-31
• Status Verified: 2023-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19	maternal SARS-CoV-2 infection	- Women with SARS-CoV-2 infections

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 RNA	1 month	levels of viral RNA from SARS-CoV-2 in breast milk

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fundacion Investigacion Sanitaria INCLIVA; 🇪🇸 Valencia, Spain

Hospital Universitario y Politecnico la Fe; 🇪🇸 Valencia, Spain