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临床试验/NCT02757794
NCT02757794已完成不适用

Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial

Assistance Publique Hopitaux De Marseille18 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2016年11月29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
166
试验地点
18
主要终点
Increase of the measuring index visuospatial

研究概览

简要总结

Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood.

Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term.

The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial.

Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea),
  • •Children aged 5 to 6 years,
  • •Children exhibiting a total intellectual quotient >70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2),
  • •Children having a visuo-spatial Working Memory impairment defined by a working memory index <85 from the WPPSI IV,
  • •Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,
  • •Children affiliated with medical insurance.

排除标准

  • •Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score >2) and Bimanual Fine Motor Function (BFMF >2) classification system (Elvrum AG 2015, Marois P 2015),
  • •Children with blindness or amblyopia, defined by a visual acuity <3 (during the 5-year assessment in EPIPAGE 2),
  • •Children with deafness, as defined by a prescribed hearing aid,
  • •Children with chromosomal disorder or autistic syndrome,
  • •Children included in the EPILANG study protocol (an ancillary project to EPIPAGE),
  • •Children who do not speak French
  • •Children with parents having no internet connection,
  • •Triplets.

研究组 & 干预措施

Cognitive remediation parents

Active Comparator

干预措施: computerized cognitive remediation program (Other)

Remediation standard

Placebo Comparator

干预措施: standard remediation (Other)

结局指标

主要结局

Increase of the measuring index visuospatial

时间窗: 18 months (more or less 2 months) post inclusion

This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.

次要结局

  • Evaluation of Education(8 months (more or less 2 months) post inclusion)
  • Assessment of intellectual functioning(8 months (more or less 2 months) post inclusion)
  • Evaluation of the working memory(18 months (more or less 2 months) post inclusion)
  • Evaluation of language and skills(8 months (more or less 2 months) post inclusion)
  • Rating behavior(8 months (more or less 2 months) post inclusion)
  • evaluation of neuropsychological development of children(8 months (more or less 2 months) post inclusion)
  • Evaluation of parental anxiety(8 months (more or less 2 months) post inclusion)
  • Assessing the quality of a child's life(8 months (more or less 2 months) post inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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