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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02757794
Acronym
EPIREMED
Enrollment
166
Registered
2016-05-02
Start date
2016-11-29
Completion date
2019-08-20
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory

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.

Interventions

OTHERcomputerized 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.

OTHERstandard remediation

A speech therapy and / or academic support is realized.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Increase of the measuring index visuospatial18 months (more or less 2 months) post inclusionThis index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.

Secondary

MeasureTime frameDescription
Evaluation of the working memory18 months (more or less 2 months) post inclusionadministering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
evaluation of neuropsychological development of children8 months (more or less 2 months) post inclusionaward of Neuropsychological Assessment test (NEPSY)
Evaluation of language and skills8 months (more or less 2 months) post inclusionpassing the test Communicate, Learn to Read and Write (KEY)
Assessment of intellectual functioning8 months (more or less 2 months) post inclusionaward of global IQ
Evaluation of parental anxiety8 months (more or less 2 months) post inclusionaward of Spielberger Trait Anxiety Inventory questionnaire
Assessing the quality of a child's life8 months (more or less 2 months) post inclusionQuality of Life Questionnaire
Evaluation of Education8 months (more or less 2 months) post inclusionEvaluation of Education is evaluated by the global adaptation school score (GSA) survey
Rating behavior8 months (more or less 2 months) post inclusionaward of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026