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临床试验/NCT01912703
NCT01912703Unknown不适用

The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
700
试验地点
1
主要终点
General Neurodevelopmental Assessment

研究概览

简要总结

It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.

研究设计

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

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm infants born at 35 weeks or less
  • Underwent at least 1 brain ultrasound
  • Diagnosed with IVH Grades 1-2
  • Had no other severe illness in NICU
  • Had neurodevelopmental follow-up

排除标准

  • All others

结局指标

主要结局

General Neurodevelopmental Assessment

时间窗: Seven years

Retrospective study of preterm infants born in the years 2007-2011 and suffered IVH Grades 1-2 who have undergone a general neurodevelopmental assessment in the Institute for Child Development in Hillel Yaffe Medical Center at ages 1-7. This assessment will indicate whether IVH Grades 1-2 has any neurodevelopmental effect on these children.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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