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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Donation intensity [Срок оценки: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.]

Вторичные конечные точки (1)

• Quality of donated human milk [Срок оценки: Assessed at the end of each donor's donation period (from first to last recorded donation), within January 1, 2021 to December 31, 2025.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Чехия · 1 центр

• Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles Universit — Prague

Идентификаторы

NCT: NCT07309146 · HUMBLE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗