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

NCT07309146 | Recruiting

• 1 other identifier: HUMBLE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactating Women - Human Milk Donors

Keywords

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

Outcome Measures

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).

  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

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

Study Arms (1)

Human Milk Donors

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

Other: No Interventions

Interventions

No Interventions OTHER

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

Human Milk Donors

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Nemocnice České Budějovice, České Budějovice, Czechia: collaborator

Study Sites (1)

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

Prague, 10000, Czechia

RECRUITING

Study Officials

• Pavel Dlouhý, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Marek Petráš, PhD

CONTACT

00420 26710 2338; marek.petras@lf3.cuni.cz

Jiří Dušek, PhD

CONTACT

00420 38 787 5700; dusek.jiri@nemcb.cz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)