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临床试验/NCT07309146
NCT07309146招募中不适用

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

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Donation intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Lactating women who donated human milk to the hospital-based human milk bank at České Budějovice Hospital during the period 2021-
  • 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.

排除标准

  • 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).

研究组 & 干预措施

Human Milk Donors

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

干预措施: No Interventions (Other)

结局指标

主要结局

Donation intensity

时间窗: 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).

次要结局

  • 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.)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marek Petras

Principal Investigator

Charles University, Czech Republic

研究点 (1)

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