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

NCT ID: NCT07309146

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Lactating Women - Human Milk Donors

Keywords

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donor human milk human milk bank milk donation milk volume milk quality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Human Milk Donors

Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025.

No Interventions

Intervention Type OTHER

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

Interventions

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No Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nemocnice České Budějovice, České Budějovice, Czechia

UNKNOWN

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Marek Petras

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pavel Dlouhý, PhD

Role: STUDY_DIRECTOR

Third Faculty of Medicine, Charles University, Prague, Czech Republic

Locations

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

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Marek Petráš, PhD

Role: CONTACT

Phone: 00420 26710 2338

Email: [email protected]

Jiří Dušek, PhD

Role: CONTACT

Phone: 00420 38 787 5700

Email: [email protected]

Facility Contacts

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Marek Petráš, assoc.prof.

Role: primary

Pavel Dlouhý, assoc.prof.

Role: backup

Other Identifiers

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HUMBLE

Identifier Type: -

Identifier Source: org_study_id