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临床试验/NCT00601081
NCT00601081已完成不适用

Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年11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
24
试验地点
1
主要终点
Cytokine profile pre and post initiation of HMF

研究概览

简要总结

This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

详细描述

In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

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
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born weighing less than 1500 grams
  • exclusive breast milk feedings with intention to fortify with human milk fortifier

排除标准

  • positive blood culture
  • history of necrotizing enterocolitis
  • significant lung disease at the start of the study

结局指标

主要结局

Cytokine profile pre and post initiation of HMF

时间窗: up to 14 days

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 (1)

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