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Clinical Trials in Czechia / NCT07309146
Recruiting Observational

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

NCT07309146 · tracked via the Priya Life Science Czechia tracker
Sponsor
Charles University, Czech Republic
Phase
Observational
Started
2026-01-01
Last updated
2026-03-18

Condition(s) studied

Lactating Women - Human Milk Donors

Investigational drug(s) / intervention(s)

No Interventions

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

Study 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
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • Donation intensity — Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.
    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).

Trial sites (1)

FacilityCityRegionStatus
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University Prague Czechia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07309146 on ClinicalTrials.gov ↗ ← All trials in Czechia