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临床试验/NCT04827524
NCT04827524已完成不适用

Investigation of Anthropometric Properties of Babies With Craniosynostosis

Yuksek Ihtisas University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020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
30
试验地点
1
主要终点
3 dimensional anthropometric analysis of the cranium

研究概览

简要总结

Craniosynostosis is a malformation affecting the head and face, in which one or more sutures in the skull are fused prematurely. Premature union of one or more sutures causes changes in the shape of the skull base and dome, resulting in asymmetrical or restricted head and facial enlargement. It has been reported that in craniosynostosis, the bone enlargement is perpendicular to the fused sutures with the counterbalancing expansion. Craniosynostosis usually involves the union of a single cranial suture, but in some cases it has been observed that it may involve more than one suture in the baby's skull. An asymmetrical appearance is observed on the faces of babies, especially an unusual appearance in the form of eyes and skulls. It may present with neurological defects such as hydrocephalus, mental retardation, vision and hearing loss, as well as cosmetic deformities in the skull and facial bones. The general prevalence of craniosynostosis is around 1/2500 births. Generally, in single suture synostoses, there is no clear neurological finding except deformity. In multisuture synostoses there are a wide spectrum of findings such as increased intracranial pressure, hydrocephalus, syringomyelia, Chiari malformation, venous anomalies, ophthalmologic problems, growth retardation and epilepsy. Early diagnosis and treatment provides enough room for the baby's brain to grow and develop. It is thought that by measuring the anthropometric properties of these babies, the course of their development will be examined.

详细描述

Babies diagnosed with craniosynostosis at birth will be included in this study. The patients will be diagnosed using a combination of physical examination, skull radiographs and 3 dimensional computerized tomography scans.A voluntary consent form will be signed by the parents of all subjects indicating that they are willing to participate in the study. Anthropometric measurements of all subjects will be measured with the Star Scanner device.

研究设计

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

入排标准

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

入选标准

  • Being under 2 years old
  • Being diagnosed with non-syndromic craniosynostosis
  • Agreeing to participate in the study

排除标准

  • Having a craniomaxillofacial fracture
  • Having a history of surgery
  • Having a congenital anomaly that affects growth or development

结局指标

主要结局

3 dimensional anthropometric analysis of the cranium

时间窗: Change from baseline anthropometric measure at 3 months.

The 3 dimensional anthropometric analysis of the subjects cranium wil be measured using the Star Scanner device.

次要结局

未报告次要终点

研究者

发起方
Yuksek Ihtisas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Volkan Yazici

Principal Investigator

Yuksek Ihtisas University

研究点 (1)

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