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 (EPIREMED)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Children Born Extremely Premature
Disturbance of Visuo-spatial Working Memory

Treatments

Other: standard remediation
Other: computerized cognitive remediation program

Study type

Interventional

Funder types

Other

Identifiers

NCT02757794
2016-01
2016-A00122-49 (Registry Identifier)
RCAPHM16_0010 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

5 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

166 participants in 2 patient groups, including a placebo group

Cognitive remediation parents
Active Comparator group
Treatment:
Other: computerized cognitive remediation program
Remediation standard
Placebo Comparator group
Treatment:
Other: standard remediation

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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