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临床试验/NCT02818595
NCT02818595已完成不适用

Development of Maternal Voice Recognition in Preterm Neonates

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
The difference in amplitude

研究概览

简要总结

Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition, tend to be processed by the right hemisphere. Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the presence of anatomical and functional asymmetries by the first months of life. What are the causes of these asymmetries? How do they develop? Are they necessary for functioning or effective learning?

This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of development at which hemispheric dominance for voice recognition is first observed and to identify the brain structure involved in preterm neonates whose sound environment is usually very different from that of the foetus. The impact of this environment on the infant's brain development and early learning will be evaluated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
0 Days 至 6 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •The distribution of children in the different groups of infants included in the study will be validated at the time of the acquisitions.
  • •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

  • •About history:
  • •All children with severe congenital malformation
  • •Regarding the study period;
  • •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 and NIRS

研究组 & 干预措施

Normal children

Experimental

Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological

干预措施: electroencephalogram (HR-EEG) (Device)

Normal children

Experimental

Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological

干预措施: Near Infra Red Spectroscopy (NIRS) (Device)

Abnormal children

Experimental

Every child meet the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological as intraventricular hemorrhage .

干预措施: electroencephalogram (HR-EEG) (Device)

Abnormal children

Experimental

Every child meet the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological as intraventricular hemorrhage .

干预措施: Near Infra Red Spectroscopy (NIRS) (Device)

结局指标

主要结局

The difference in amplitude

时间窗: 10 weeks

The difference in amplitude of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response

The difference in latency

时间窗: 10 weeks

The difference in latency of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response

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 (1)

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