Impact of Maternal COVID-19 Vaccines on Breast Milk

Completed

• Conditions: COVID-19 Vaccines
• Interventions: Biological: Covid vaccines

• Registration Number: NCT04751734
• 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 vaccination on breast milk immune, microbiological, and metabolic profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-16
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.

Exclusion Criteria

• cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinations	Covid vaccines	SARS-CoV-2 vaccination

Primary Outcome Measures

Name	Time	Method
Antibodies	1st year	presence and levels of antibodies

Secondary Outcome Measures

Name	Time	Method
infant microbiota	1st year	infant microbiota composition and diversity
breast milk bioactive composition	1st year	metabolite profile
infant growth and development	1st year	z-scores growth curves

Trial Locations

Locations (2)

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

Fundacion Investigacion Sanitaria INCLIVA; 🇪🇸 Valencia, Spain