Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Interventions.
- Who it may be relevant to
- Registry conditions: Lactating Women - Human Milk Donors. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Quantity and Quality of Human Breast Milk Collected in a Single-center Milk Bank Over the Last Five Years
Overview
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.
Interventions
- Other No Interventions
Retrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered.
Primary outcome measures
- Donation intensity [Time frame: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.]
Secondary outcome measures (1)
- Quality of donated human milk [Time frame: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Czechia · 1 center
- Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles Universit — Prague
Identifiers
NCT: NCT07309146 · HUMBLE