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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 20, 2019

Interventions

  • Other: computerized cognitive remediation program
    • a computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session.
  • Other: standard remediation
    • A speech therapy and / or academic support is realized.

Arms, Groups and Cohorts

  • Active Comparator: Cognitive remediation parents
  • Placebo Comparator: Remediation standard

Clinical Trial Outcome Measures

Primary Measures

  • Increase of the measuring index visuospatial
    • Time Frame: 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.

Secondary Measures

  • Assessment of intellectual functioning
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • award of global IQ
  • Evaluation of the working memory
    • Time Frame: 18 months (more or less 2 months) post inclusion
    • administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
  • evaluation of neuropsychological development of children
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • award of Neuropsychological Assessment test (NEPSY)
  • Evaluation of language and skills
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • passing the test Communicate, Learn to Read and Write (KEY)
  • Rating behavior
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))
  • Evaluation of parental anxiety
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • award of Spielberger Trait Anxiety Inventory questionnaire
  • Assessing the quality of a child’s life
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • Quality of Life Questionnaire
  • Evaluation of Education
    • Time Frame: 8 months (more or less 2 months) post inclusion
    • Evaluation of Education is evaluated by the global adaptation school score (GSA) survey

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique Hopitaux De Marseille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Urielle DESALBRES, Director, Study Director, Assistance Publique Hôpitaux de Marseille

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