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Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation (EPIREM)

Primary Purpose

Premature Childbirth

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI) 3 tesla
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Childbirth

Eligibility Criteria

8 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
  • Possessing an intelligence quotient (IQ) greater than 70

Exclusion Criteria:

  • Child not understanding French
  • Child who did not have all the interventions in the EPIREMED study

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group exposed to cognitive remediation

Group not exposed to cognitive remediation

Arm Description

Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)

Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)

Outcomes

Primary Outcome Measures

Activation of cortical areas
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory

Secondary Outcome Measures

Full Information

First Posted
May 31, 2019
Last Updated
May 31, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03972761
Brief Title
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
Acronym
EPIREM
Official Title
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2019 (Anticipated)
Primary Completion Date
September 26, 2021 (Anticipated)
Study Completion Date
September 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives. In addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM). The main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years). The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned It is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla. The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place). The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Childbirth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group exposed to cognitive remediation
Arm Type
Active Comparator
Arm Description
Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
Arm Title
Group not exposed to cognitive remediation
Arm Type
Placebo Comparator
Arm Description
Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI) 3 tesla
Intervention Description
Functional neuroimaging objectifies the activation of specific areas of the brain
Primary Outcome Measure Information:
Title
Activation of cortical areas
Description
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children born between 24 and 34 weeks of amenorrhea and living in the Provence region Possessing an intelligence quotient (IQ) greater than 70 Exclusion Criteria: Child not understanding French Child who did not have all the interventions in the EPIREMED study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barthélémy TOSELLO, PH
Phone
491968300
Ext
+33
Email
barthelemy.tosello@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barthélémy TOSELLO, PH
Phone
491968300
Ext
+33
Email
barthelemy.tosello@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Barthélémy TOSELLO, PH

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation

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