[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616710":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":28,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":67,"collaborators":71,"id":75,"slug":17,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":17,"studyType":89,"phases":17,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14],{"measure":15,"description":16,"timeFrame":12},"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\u002FL), protein (g\u002FL), carbohydrate (g\u002FL), and calculated energy content (kcal\u002F100 mL) Microbiological safety indicators: total viable bacterial count (CFU\u002FmL) and culture result classified as pass\u002Ffail according to the milk bank's routine acceptance criteria",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":6,"timePerspective":19,"maskingInfo":17},"CROSS_SECTIONAL","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.","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.",[23],{"label":24,"type":17,"description":25,"interventionNames":26},"Human Milk Donors","Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital between 2021 and 2025.",[27],"Other: No Interventions",[29],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":17},"No Interventions","Retrospective observational study based on routinely collected clinical and milk bank data; no experimental procedure, treatment, or behavioral intervention is administered.",[24],[34],{"name":35,"affiliation":36,"role":37},"Pavel Dlouhý, PhD","Third Faculty of Medicine, Charles University, Prague, Czech Republic","STUDY_DIRECTOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},"Marek Petráš, PhD","CONTACT","00420 26710 2338","marek.petras@lf3.cuni.cz",{"name":45,"role":41,"phone":46,"phoneExt":17,"email":47},"Jiří Dušek, PhD","00420 38 787 5700","dusek.jiri@nemcb.cz",[49],{"facility":50,"status":51,"city":52,"state":17,"zip":53,"country":54,"countryCode":17,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University","RECRUITING","Prague","10000","Czechia",{"type":56,"coordinates":57},"Point",[58,59],14.42076,50.08804,{"lat":59,"lon":58},[62,64],{"name":63,"role":41,"phone":42,"phoneExt":17,"email":43},"Marek Petráš, assoc.prof.",{"name":65,"role":41,"phone":17,"phoneExt":17,"email":66},"Pavel Dlouhý, assoc.prof.","pavel.dlouhy@lf3.cuni.cz",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Marek Petras","Principal Investigator",[72],{"name":73,"class":74},"Nemocnice České Budějovice, České Budějovice, Czechia","UNKNOWN","100616710",false,"NCT07309146","Single-center Evaluation of Human Milk Quantity and Quality Over Five Years","Evaluation of the Quantity and Quality of Human Breast Milk Collected in a Single-center Milk Bank Over the Last Five Years","HUMBLE","Inclusion Criteria:\n\n* Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital during the period 2021-2025.\n* Accepted as donors according to local eligibility criteria for human milk donation.\n* At least one recorded donation of human milk with available data on donation date and volume in the milk bank database.\n* Availability of basic maternal and perinatal data (e.g., age, BMI, parity, mode of delivery, timing of donation) in the hospital information sys-tem.\n\nExclusion Criteria:\n\n* Donors with no recorded volume or date of human milk donation in the milk bank database.\n* Records with evident data errors or inconsistencies that cannot be reliably corrected (e.g., implausible dates or volumes).",true,"FEMALE","18 Years","50 Years",{"count":87,"type":88},500,"ESTIMATED","OBSERVATIONAL","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.",[92],"Lactating Women - Human Milk Donors",[94,95,96,97,98],"donor human milk","human milk bank","milk donation","milk volume","milk quality","2026-03-16",{"date":101,"type":102},"2026-03-18","ACTUAL",{"date":104,"type":102},"2026-01-01",{"date":106,"type":88},"2026-09-30",{"name":5,"class":6},1]