NCT07309146 Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
| NCT ID | NCT07309146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charles University, Czech Republic |
| Condition | Lactating Women - Human Milk Donors |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-01-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Pavel Dlouhý, PhD
STUDY DIRECTOR
Third Faculty of Medicine, Charles University, Prague, Czech Republic
Frequently Asked Questions
Who can join the NCT07309146 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Lactating Women - Human Milk Donors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309146 currently recruiting?
Yes, NCT07309146 is actively recruiting participants. Contact the research team at marek.petras@lf3.cuni.cz for enrollment information.
Where is the NCT07309146 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT07309146 clinical trial?
NCT07309146 is sponsored by Charles University, Czech Republic. The principal investigator is Pavel Dlouhý, PhD at Third Faculty of Medicine, Charles University, Prague, Czech Republic. The trial plans to enroll 500 participants.