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临床试验/NCT02988570
NCT02988570已完成不适用

Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年11月10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
49
试验地点
1
主要终点
Evaluation of comprehension of words and phrases level

研究概览

简要总结

In recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. These language impairments lead to learning disabilities. There are, however, contradictions concerning the origin and nature of language dysfunctions. Some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations).

The computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. The language assessment lasts 30 to 45 minutes per child. It is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. The language evaluation scale is the battery CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language evaluation. The assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. Each time, the child sees images and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm.

The evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. This assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write.

The expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. These screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children born very preterm in 2011 in the region of Haute-Normandie in France

排除标准

  • 未提供

结局指标

主要结局

Evaluation of comprehension of words and phrases level

时间窗: Day 1

A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.

次要结局

  • Evaluation of production of words and phrases level(Day 1)
  • Evaluation of judgment of sentences level(Day 1)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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