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

Charles University, Czech Republic

Status

Not yet enrolling

Conditions

Lactating Women - Human Milk Donors

Treatments

Other: No Interventions

Study type

Observational

Funder types

Other

Identifiers

NCT07309146

HUMBLE

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital during the period 2021-2025.
Accepted as donors according to local eligibility criteria for human milk donation.
At least one recorded donation of human milk with available data on donation date and volume in the milk bank database.
Availability of basic maternal and perinatal data (e.g., age, BMI, parity, mode of delivery, timing of donation) in the hospital information sys-tem.

Exclusion criteria

Donors with no recorded volume or date of human milk donation in the milk bank database.
Records with evident data errors or inconsistencies that cannot be reliably corrected (e.g., implausible dates or volumes).