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| Name | Class |
|---|---|
| Nemocnice České Budějovice, České Budějovice, Czechia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Milk Donors | Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Interventions | Other | Retrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Petráš, PhD | Contact | 00420 26710 2338 | marek.petras@lf3.cuni.cz | |
| Jiří Dušek, PhD | Contact | 00420 38 787 5700 | dusek.jiri@nemcb.cz |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Dlouhý, PhD | Third Faculty of Medicine, Charles University, Prague, Czech Republic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University | Recruiting | Prague | 10000 | Czechia |
Individual participant data will not be shared due to the sensitive nature of donor information, absence of explicit consent for external data sharing, and restrictions imposed by local regulations and GDPR.
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| Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025. |