跳至主要内容
临床试验/NCT01626508
NCT01626508已完成不适用

Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA

研究概览

简要总结

The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 12 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Parent's written informed consent
  • Gestational age less than 33 weeks of amenorrhea
  • Hospitalisation in an NICU at the time of inclusion
  • Intended enteral nutrition with breast milk

排除标准

  • Persons not covered by the French social security system
  • Major congenital malformation
  • Participation in other biomedical study protocols
  • Babies that are likely to be transferred to another hospital during the study period

结局指标

主要结局

Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA

时间窗: 3 weeks after the establishment of enteral nutrition

* Level of total FA and composition of FA on samples of untreated breast milk immediately after the milk has been expressed * Level of total FA and composition of FA on samples of breast milk provided by the milk bank just before being given to the infant

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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