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临床试验/NCT01810978
NCT01810978已完成不适用

Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease

Dr. Sami Ulus Children's Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Sepsis

研究概览

简要总结

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD

详细描述

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD

研究设计

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

入排标准

年龄范围
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Cyanotic congenital heart disease
  • infants >35 weeks of gestational age
  • Born at or transferred to Sami Ulus CH

排除标准

  • Congenital anomalies of the intestinal tract

结局指标

主要结局

Sepsis

时间窗: 8 weeks

次要结局

  • Necrotizing enterocolitis(8 weeks)

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 (2)

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