NCT07309146

Single-center Evaluation of Human Milk Quantity and Quality Over Five Years

Evaluation of the Quantity and Quality of Human Breast Milk Collected in a Single-center Milk Bank Over the Last Five Years

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This single-center retrospective observational study includes all human milk donors collaborating with the milk bank at České Budějovice Hospital between 2021 and 2025. Using anonymized data extracted from the hospital database, the study will quantify the frequency of donations and the individual and cumulative volume of donated human milk and will assess the impact of key maternal and perinatal factors - including age, BMI, parity, mode of delivery, and timing of donations - on the quantity and quality of donated milk, based on routine biochemical and microbiological parameters.

Detailed description

Donor human milk is a key component of nutritional care for preterm and high-risk neonates when mother's own milk is unavailable or insufficient. A better under-standing of which factors are associated with higher or lower donated volumes, and with favorable biochemical and microbiological milk characteristics, may help optimize several aspects of milk bank practice. This study aims to characterize a five-year experience from a single hospital-based human milk bank in terms of donation pat-terns and donated milk volume. It also aims to evaluate the relationship between key maternal and perinatal characteristics and both the quantity and routinely assessed quality of donated human milk.

Conditions

• Lactating Women - Human Milk Donors

Interventions

Type	Name	Description
OTHER	No Interventions	Retrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-30
• Completion: 2026-09-30
• First posted: 2025-12-30
• Last updated: 2026-03-18

Locations

1 site across 1 country: Czechia