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临床试验/NCT01305642
NCT01305642已完成不适用

Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

McMaster Children's Hospital2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2011年2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
13
试验地点
2
主要终点
growth

研究概览

简要总结

To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Birth weight ≤ 1500g and gestational age < 32weeks
  • Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h

排除标准

  • Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk
  • gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities
  • Babies with enterostoma or short gut syndrome
  • Fluid restriction below
  • Renal disease
  • Necrotizing enterocolitis
  • Hepatic dysfunction

结局指标

主要结局

growth

时间窗: from inclusion at postmentrual age <32 weeks until 36 weeks

weight gain will be accessed three times per week

次要结局

  • enteral energy intake(from inclusion at postmentrual age <32 weeks until 36 weeks)
  • growth, tolerance, morbidity(from inclusion at postmentrual age <32 weeks until 36 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Fusch

Professor and Division Head

McMaster Children's Hospital

研究点 (2)

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