跳至主要内容
临床试验/NCT02826733
NCT02826733已完成不适用

Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
discrimination of language - EEG

研究概览

简要总结

Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning?

The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.

研究设计

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

入排标准

年龄范围
0 Days 至 10 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks.
  • normal group of children : A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).
  • Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

排除标准

  • severe congenital malformation
  • Any refusal of a parent .
  • Children with severe impairment of the general condition and vital functions
  • Children with dermatitis of the face or scalp
  • Children treated with ventilation High Frequency (HFO )
  • Presence of intravenous access on the scalp ( preventing the realization of the ETF , EEG or NIRS .

结局指标

主要结局

discrimination of language - EEG

时间窗: Day 0

Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the EEG signals

discrimination of language - NIRS

时间窗: Day 0

Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the NIRS signals

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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