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Completed

NCT Number: NCT02757794

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

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.

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Key information

Conditions

Children Born Extremely Premature Disturbance of Visuo-spatial Working Memory

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Lyon, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

computerized cognitive remediation program

Other

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.

standard remediation

Other

A speech therapy and / or academic support is realized.

Primary outcomes

  1. 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 outcomes

  1. Assessment of intellectual functioning

    Time frame: 8 months (more or less 2 months) post inclusion

    award of global IQ

  2. 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)

  3. evaluation of neuropsychological development of children

    Time frame: 8 months (more or less 2 months) post inclusion

    award of Neuropsychological Assessment test (NEPSY)

  4. 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)

  5. Rating behavior

    Time frame: 8 months (more or less 2 months) post inclusion

    award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))

  6. Evaluation of parental anxiety

    Time frame: 8 months (more or less 2 months) post inclusion

    award of Spielberger Trait Anxiety Inventory questionnaire

  7. Assessing the quality of a child's life

    Time frame: 8 months (more or less 2 months) post inclusion

    Quality of Life Questionnaire

  8. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: EPIREMED

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 2, 2016
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.