Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Born Extremely Premature
Disturbance of Visuo-spatial Working Memory
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 166
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Increase of the measuring index visuospatial
timeFrame: 18 months (more or less 2 months) post inclusion
Secondary outcomes:
measure: Assessment of intellectual functioning
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Evaluation of the working memory
timeFrame: 18 months (more or less 2 months) post inclusion
measure: evaluation of neuropsychological development of children
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Evaluation of language and skills
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Rating behavior
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Evaluation of parental anxiety
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Assessing the quality of a child's life
timeFrame: 8 months (more or less 2 months) post inclusion
measure: Evaluation of Education
timeFrame: 8 months (more or less 2 months) post inclusion
Other outcomes:
Locations:
city: Bron
country: France
facility: University Hospital of Lyon
city: Caen
country: France
facility: University Hospital of Caen Normandie
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Corbeil-Essonnes
country: France
facility: Sud Francilien Hospital
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nancy
country: France
facility: Regional University Hospital of Nancy
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Nîmes
country: France
facility: University Hospital of Nîmes
city: Paris
country: France
facility: AP- HP - Armand Trousseau Hospital
city: Reims
country: France
facility: University Hospital of Reims
city: Rouen
country: France
facility: University Hospital of Rouen
city: St Etienne
country: France
facility: University Hospital of Saint-Etienne
city: Strasbourg
country: France
facility: Regional University Hospital of Strasbourg
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Tours
country: France
facility: University Hospital of Tour
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES, Director
role: STUDY_DIRECTOR
References:
citation: 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.