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

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ClinicalTrials.gov Identifier: NCT03972761
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date  ICMJE September 27, 2019
Estimated Primary Completion Date September 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Activation of cortical areas [ Time Frame: 24 months ]
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
Official Title  ICMJE Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Premature Childbirth
Intervention  ICMJE Device: Magnetic Resonance Imaging (MRI) 3 tesla
Functional neuroimaging objectifies the activation of specific areas of the brain
Study Arms  ICMJE
  • Active Comparator: Group exposed to cognitive remediation
    Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
    Intervention: Device: Magnetic Resonance Imaging (MRI) 3 tesla
  • Placebo Comparator: Group not exposed to cognitive remediation
    Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
    Intervention: Device: Magnetic Resonance Imaging (MRI) 3 tesla
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 26, 2021
Estimated Primary Completion Date September 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barthélémy TOSELLO, PH 491968300 ext +33 barthelemy.tosello@ap-hm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972761
Other Study ID Numbers  ICMJE 2019-07
2019-A00829-48 ( Other Identifier: ID RCB )
RCAPHM19_0023 ( Other Identifier: Secondary AP-HM number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP