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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lactating Women - Human Milk Donors
• Intervention / Treatment: Other: No Interventions

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Marek Petráš, PhD; Phone Number: 00420 26710 2338; Email: marek.petras@lf3.cuni.cz
• Study Contact Backup: Name: Jiří Dušek, PhD; Phone Number: 00420 38 787 5700; Email: dusek.jiri@nemcb.cz

Study Locations

• Czechia
  • Prague, Czechia, 10000
    • Recruiting
    • Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
    • Contact: Marek Petráš, assoc.prof.; Phone Number: 00420 26710 2338; Email: marek.petras@lf3.cuni.cz
    • Contact: Pavel Dlouhý, assoc.prof.; Email: pavel.dlouhy@lf3.cuni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of donated human milk	Quality of donated human milk, assessed by routine biochemical composition parameters and microbiological safety indicators over the individual donation period within the 5-year study window (2021-2025). Biochemical composition parameters: fat (g/L), protein (g/L), carbohydrate (g/L), and calculated energy content (kcal/100 mL) Microbiological safety indicators: total viable bacterial count (CFU/mL) and culture result classified as pass/fail according to the milk bank's routine acceptance criteria	Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Nemocnice České Budějovice, České Budějovice, Czechia
• Investigators: Study Director: Pavel Dlouhý, PhD, Third Faculty of Medicine, Charles University, Prague, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: donor human milk; milk volume; human milk bank; milk donation; milk quality
• Other Study ID Numbers: HUMBLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the sensitive nature of donor information, absence of explicit consent for external data sharing, and restrictions imposed by local regulations and GDPR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No