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
NCT ID: NCT02757794
Last Updated: 2023-07-06
Study Results
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Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2016-11-29
2019-08-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cognitive remediation parents
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.
Remediation standard
standard remediation
A speech therapy and / or academic support is realized.
Interventions
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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.
standard remediation
A speech therapy and / or academic support is realized.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
6 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Urielle DESALBRES, Director
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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University Hospital of Lyon
Bron, , France
University Hospital of Caen Normandie
Caen, , France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, , France
Sud Francilien Hospital
Corbeil-Essonnes, , France
University Hospital of Grenoble
Grenoble, , France
Assistance Publique Hôpitaux de Marseille
Marseille, , France
University Hospital of Montpellier
Montpellier, , France
Regional University Hospital of Nancy
Nancy, , France
University Hospital of Nantes
Nantes, , France
University Hospital of Nice
Nice, , France
University Hospital of Nîmes
Nîmes, , France
AP- HP - Armand Trousseau Hospital
Paris, , France
University Hospital of Reims
Reims, , France
University Hospital of Rouen
Rouen, , France
University Hospital of Saint-Etienne
Saint-Etienne, , France
Regional University Hospital of Strasbourg
Strasbourg, , France
University Hospital of Toulouse
Toulouse, , France
University Hospital of Tour
Tours, , France
Countries
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References
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Gire C, Beltran Anzola A, Marret S, Foix L'Helias L, Roze JC, Granier M, Patural H, Lecomte B, Guillois B, Souksi Medioni I, Bednarek Weirauch N, Claris O, Hascoet JM, Kuhn P, Zahed M, Boucekine M, Ancel PY, Arnaud C, Cambonie G, Dorriere Datin V; EPIREMED Study Group. Cognitive Training for Visuospatial Processing in Children Aged 5(1/2) to 6 Years Born Very Preterm With Working Memory Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331988. doi: 10.1001/jamanetworkopen.2023.31988.
Gire C, Beltran Anzola A, Kaminski M, Baumstarck K, Ancel PY, Berbis J; for EPIREMED-Study Group. A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. BMC Pediatr. 2021 Sep 13;21(1):402. doi: 10.1186/s12887-021-02867-x.
Other Identifiers
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2016-A00122-49
Identifier Type: REGISTRY
Identifier Source: secondary_id
RCAPHM16_0010
Identifier Type: OTHER
Identifier Source: secondary_id
2016-01
Identifier Type: -
Identifier Source: org_study_id
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