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临床试验/NCT01850784
NCT01850784Unknown不适用

High Energy Formula Feeding in Infants With Congenital Heart Disease

Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Weight gain

研究概览

简要总结

High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

详细描述

Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infants >35 weeks of gestational age
  • infants with CHD
  • İnfants fed with formula feeding

排除标准

  • xclusion Criteria:
  • Major congenital abnormalities except CHD
  • infants could not be fed enterally

结局指标

主要结局

Weight gain

时间窗: 6 weeks

次要结局

  • Neurodevelopmental evaluation(18 months)

研究者

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

Assoc Prof

Dr. Sami Ulus Children's Hospital

研究点 (1)

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