About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025. All donors met the local eligi-bility criteria for milk donation and collaborated with the milk bank during the de-fined period.
Trial design
Other
Cross-sectional
Treatments tested in this trial
No Interventions
Other interventionRetrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered.
Treatment groups
Trial outcomes
Primary outcomes
Donation intensity
Donation intensity, defined as the cumulative volume of donated human milk per donor (mL) and the number of donation episodes per donor over the individual donation period within the 5-year study window (2021-2025).
Secondary outcomes
Quality of donated human milk
Quality of donated human milk, assessed by routine biochemical composition parameters and microbiological safety indicators over the individual donation period within the 5-year study window (2021-2025). Biochemical composition parameters: fat (g/L), protein (g/L), carbohydrate (g/L), and calculated energy content (kcal/100 mL) Microbiological safety indicators: total viable bacterial count (CFU/mL) and culture result classified as pass/fail according to the milk bank's routine acceptance criteria
Sponsors and contacts
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Charles University, Czech Republic
Lead sponsor
Nemocnice České Budějovice, České Budějovice, Czechia
Collaborator