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临床试验/NCT00077831
NCT00077831已完成不适用

Neurobehavioral Correlates of Craniosynostosis

Seattle Children's Hospital4 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2001年9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
535
试验地点
4
主要终点
Neurodevelopment as assessed by the Bayley Scales of Infant Development II

研究概览

简要总结

To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

详细描述

In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. A case-matched "control" group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Neurodevelopment as assessed by the Bayley Scales of Infant Development II

时间窗: 1st assessment - post diagnosis, pre surgery. 2nd assessment - Target age 18 months. 3rd assessment - Target age 36 months.

次要结局

  • Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV(Target age 7 years)

研究者

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

Matt Speltz

Principal Investigator

Seattle Children's Hospital

研究点 (4)

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