RecruitingNCT07309146

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

Evaluation of the Quantity and Quality of Human Breast Milk Collected in a Single-center Milk Bank Over the Last Five Years


Sponsor

Charles University, Czech Republic

Enrollment

500 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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).

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Interventions

OTHERNo Interventions

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


Locations(1)

Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University

Prague, Czechia

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NCT07309146