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
- Conditions
- Children Born Extremely PrematureDisturbance of Visuo-spatial Working Memory
- Interventions
- Other: computerized cognitive remediation programOther: standard remediation
- Registration Number
- NCT02757794
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive remediation parents computerized cognitive remediation program - Remediation standard standard remediation -
- Primary Outcome Measures
Name Time Method Increase of the measuring index visuospatial 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 Outcome Measures
Name Time Method Evaluation of Education 8 months (more or less 2 months) post inclusion Evaluation of Education is evaluated by the global adaptation school score (GSA) survey
Assessment of intellectual functioning 8 months (more or less 2 months) post inclusion award of global IQ
Evaluation of the working memory 18 months (more or less 2 months) post inclusion administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
Evaluation of language and skills 8 months (more or less 2 months) post inclusion passing the test Communicate, Learn to Read and Write (KEY)
Rating behavior 8 months (more or less 2 months) post inclusion award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))
evaluation of neuropsychological development of children 8 months (more or less 2 months) post inclusion award of Neuropsychological Assessment test (NEPSY)
Evaluation of parental anxiety 8 months (more or less 2 months) post inclusion award of Spielberger Trait Anxiety Inventory questionnaire
Assessing the quality of a child's life 8 months (more or less 2 months) post inclusion Quality of Life Questionnaire
Trial Locations
- Locations (18)
University Hospital of Caen Normandie
🇫🇷Caen, France
University Hospital of Grenoble
🇫🇷Grenoble, France
University Hospital of Lyon
🇫🇷Bron, France
Regional University Hospital of Nancy
🇫🇷Nancy, France
University Hospital of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
University Hospital of Montpellier
🇫🇷Montpellier, France
AP- HP - Armand Trousseau Hospital
🇫🇷Paris, France
Assistance Publique Hôpitaux de Marseille
🇫🇷Marseille, France
University Hospital of Rouen
🇫🇷Rouen, France
Sud Francilien Hospital
🇫🇷Corbeil-Essonnes, France
University Hospital of Tour
🇫🇷Tours, France
University Hospital of Nantes
🇫🇷Nantes, France
University Hospital of Nice
🇫🇷Nice, France
University Hospital of Nîmes
🇫🇷Nîmes, France
University Hospital of Reims
🇫🇷Reims, France
University Hospital of Saint-Etienne
🇫🇷St Etienne, France
University Hospital of Toulouse
🇫🇷Toulouse, France
Regional University Hospital of Strasbourg
🇫🇷Strasbourg, France