NCT03972761

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 31, 2019

Last Update Submit

May 31, 2019

Conditions

Premature Childbirth

Outcome Measures

Primary Outcomes (1)

  • Activation of cortical areas

    Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory

    24 months

Study Arms (2)

Group exposed to cognitive remediation

ACTIVE COMPARATOR

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

Device: Magnetic Resonance Imaging (MRI) 3 tesla

Group not exposed to cognitive remediation

PLACEBO COMPARATOR

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

Device: Magnetic Resonance Imaging (MRI) 3 tesla

Interventions

Magnetic Resonance Imaging (MRI) 3 teslaDEVICE

Functional neuroimaging objectifies the activation of specific areas of the brain

Group exposed to cognitive remediationGroup not exposed to cognitive remediation

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jean-Olivier ARNAUD, Director

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Barthélémy TOSELLO, PH

CONTACT

491968300barthelemy.tosello@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 4, 2019

Study Start

September 27, 2019

Primary Completion

September 26, 2021

Study Completion

September 26, 2021

Last Updated

June 4, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)