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)
Primary Purpose
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computerized cognitive remediation program
standard remediation
Sponsored by
About this trial
This is an interventional supportive care trial for Children Born Extremely 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.
Sites / Locations
- University Hospital of Lyon
- University Hospital of Caen Normandie
- University Hospital of Clermont-Ferrand
- Sud Francilien Hospital
- University Hospital of Grenoble
- Assistance Publique Hôpitaux de Marseille
- University Hospital of Montpellier
- Regional University Hospital of Nancy
- University Hospital of Nantes
- University Hospital of Nice
- University Hospital of Nîmes
- AP- HP - Armand Trousseau Hospital
- University Hospital of Reims
- University Hospital of Rouen
- University Hospital of Saint-Etienne
- Regional University Hospital of Strasbourg
- University Hospital of Toulouse
- University Hospital of Tour
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cognitive remediation parents
Remediation standard
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessment of intellectual functioning
award of global IQ
Evaluation of the working memory
administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
evaluation of neuropsychological development of children
award of Neuropsychological Assessment test (NEPSY)
Evaluation of language and skills
passing the test Communicate, Learn to Read and Write (KEY)
Rating behavior
award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))
Evaluation of parental anxiety
award of Spielberger Trait Anxiety Inventory questionnaire
Assessing the quality of a child's life
Quality of Life Questionnaire
Evaluation of Education
Evaluation of Education is evaluated by the global adaptation school score (GSA) survey
Full Information
NCT ID
NCT02757794
First Posted
April 28, 2016
Last Updated
July 3, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02757794
Brief 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
Acronym
EPIREMED
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive remediation parents
Arm Type
Active Comparator
Arm Title
Remediation standard
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
computerized cognitive remediation program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard remediation
Intervention Description
A speech therapy and / or academic support is realized.
Primary Outcome Measure Information:
Title
Increase of the measuring index visuospatial
Description
This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.
Time Frame
18 months (more or less 2 months) post inclusion
Secondary Outcome Measure Information:
Title
Assessment of intellectual functioning
Description
award of global IQ
Time Frame
8 months (more or less 2 months) post inclusion
Title
Evaluation of the working memory
Description
administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
Time Frame
18 months (more or less 2 months) post inclusion
Title
evaluation of neuropsychological development of children
Description
award of Neuropsychological Assessment test (NEPSY)
Time Frame
8 months (more or less 2 months) post inclusion
Title
Evaluation of language and skills
Description
passing the test Communicate, Learn to Read and Write (KEY)
Time Frame
8 months (more or less 2 months) post inclusion
Title
Rating behavior
Description
award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))
Time Frame
8 months (more or less 2 months) post inclusion
Title
Evaluation of parental anxiety
Description
award of Spielberger Trait Anxiety Inventory questionnaire
Time Frame
8 months (more or less 2 months) post inclusion
Title
Assessing the quality of a child's life
Description
Quality of Life Questionnaire
Time Frame
8 months (more or less 2 months) post inclusion
Title
Evaluation of Education
Description
Evaluation of Education is evaluated by the global adaptation school score (GSA) survey
Time Frame
8 months (more or less 2 months) post inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
University Hospital of Caen Normandie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital of Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Sud Francilien Hospital
City
Corbeil-Essonnes
ZIP/Postal Code
91 106
Country
France
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38 043
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Regional University Hospital of Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
University Hospital of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06300
Country
France
Facility Name
University Hospital of Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
AP- HP - Armand Trousseau Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
University Hospital of Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
University Hospital of Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
University Hospital of Saint-Etienne
City
St Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Regional University Hospital of Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital of Tour
City
Tours
ZIP/Postal Code
37000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34517869
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.
Results Reference
derived
Learn more about this 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
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