Lactating Women - Human Milk DonorsHUMBLENCT07309146
Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
An observational study of Lactating Women - Human Milk Donors, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactating Women - Human Milk Donors
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
Prague, 10000
Marek Petráš, assoc.prof., 00420 26710 2338, marek.petras@lf3.cuni.cz
Pavel Dlouhý, assoc.prof., pavel.dlouhy@lf3.cuni.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Lactating Women - Human Milk Donors
- Being tested
- No Interventions
- Keywords
- donor human milk, human milk bank, milk donation, milk volume, milk quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
Retrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Human Milk Donors | Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026
- Primary completion30 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactating Women - Human Milk DonorsStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Nemocnice České Budějovice, České Budějovice, Czechia
- Responsible party
- Principal investigator, Marek Petras, Charles University, Czech Republic
- Investigators
- Pavel Dlouhý, PhD, Study director, Third Faculty of Medicine, Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309146
- Sponsor's protocol ID
- HUMBLE
- Acronym
- HUMBLE
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quantity and Quality of Human Breast Milk Collected in a Single-center Milk Bank Over the Last Five Years
- ClinicalTrials.gov ID
- NCT07309146
- Acronym / sponsor ID
- HUMBLE / HUMBLE
- Conditions
- Lactating Women - Human Milk Donors
- Keywords
- donor human milk, human milk bank, milk donation, milk volume, milk quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Nemocnice České Budějovice, České Budějovice, Czechia
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Milk Donors | – | Other: No InterventionsLactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsRetrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered. | Other | Human Milk Donors |
Primary outcome
Donation intensity
Time frame: 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).
1 secondary outcome
Quality of donated human milk
Time frame: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pavel Dlouhý, PhD study director
Third Faculty of Medicine, Charles University, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactating Women - Human Milk Donors, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Petráš, PhD (00420 26710 2338, marek.petras@lf3.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donation intensity (time frame: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.