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)

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.

Study Overview

• Status: Completed
• Conditions: Children Born Extremely Premature; Disturbance of Visuo-spatial Working Memory
• Intervention / Treatment: Other: computerized cognitive remediation program; Other: standard remediation

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine GIRE, PI; Phone Number: 0491964827; Email: catherine.gire@ap-hm.fr

Study Locations

• France
  • Bron, France, 69677
    • University Hospital of Lyon
  • Caen, France, 14033
    • University Hospital of Caen Normandie
  • Clermont-Ferrand, France, 63003
    • University Hospital of Clermont-Ferrand
  • Corbeil-Essonnes, France, 91 106
    • Sud Francilien Hospital
  • Grenoble, France, 38 043
    • University hospital of Grenoble
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille
  • Montpellier, France, 34295
    • University Hospital of Montpellier
  • Nancy, France, 54035
    • Regional University Hospital of Nancy
  • Nantes, France, 44093
    • University Hospital of Nantes
  • Nice, France, 06300
    • University Hospital of Nice
  • Nîmes, France, 30029
    • University Hospital of Nîmes
  • Paris, France, 75012
    • AP- HP - Armand Trousseau Hospital
  • Reims, France, 51092
    • University Hospital of Reims
  • Rouen, France, 76031
    • University Hospital of Rouen
  • St Etienne, France, 42055
    • University Hospital of Saint-Etienne
  • Strasbourg, France, 67200
    • Regional University Hospital of Strasbourg
  • Toulouse, France, 31059
    • University Hospital of Toulouse
  • Tours, France, 37000
    • University Hospital of Tour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive remediation parents	Other: 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.
Placebo Comparator: Remediation standard	Other: standard remediation; A speech therapy and / or academic support is realized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase of the measuring index visuospatial	This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.	18 months (more or less 2 months) post inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the working memory	administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)	18 months (more or less 2 months) post inclusion
Assessment of intellectual functioning	award of global IQ	8 months (more or less 2 months) post inclusion
evaluation of neuropsychological development of children	award of Neuropsychological Assessment test (NEPSY)	8 months (more or less 2 months) post inclusion
Evaluation of language and skills	passing the test Communicate, Learn to Read and Write (KEY)	8 months (more or less 2 months) post inclusion
Rating behavior	award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))	8 months (more or less 2 months) post inclusion
Evaluation of parental anxiety	award of Spielberger Trait Anxiety Inventory questionnaire	8 months (more or less 2 months) post inclusion
Assessing the quality of a child's life	Quality of Life Questionnaire	8 months (more or less 2 months) post inclusion
Evaluation of Education	Evaluation of Education is evaluated by the global adaptation school score (GSA) survey	8 months (more or less 2 months) post inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Urielle DESALBRES, Director, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimated): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: 2016-01; 2016-A00122-49 (Registry Identifier: ID RCB); RCAPHM16_0010 (Other Identifier: APHM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED