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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorCharles University, Czech Republic

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Interventions

    Other intervention

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Human Milk Donors1 intervention

Trial outcomes

Primary outcomes

1

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).

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 outcomes

1

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

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.

Other outcomes

Sponsors and contacts

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Charles University, Czech Republic

Lead sponsor

Nemocnice České Budějovice, České Budějovice, Czechia

Collaborator