Evaluation of Brain Plasticity in Premature Infants at Sc... | NCT03972761

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

NCT03972761

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Jun 4, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Premature Childbirth

Interventions

Magnetic Resonance Imaging (MRI) 3 tesla

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A00829-48	Other Identifier	ID RCB
RCAPHM19_0023	Other Identifier	Secondary AP-HM number

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2019Estimated

Primary Completion Date

Sep 26, 2021Estimated

Completion Date

Sep 26, 2021Estimated

First Submitted Date

May 31, 2019

First Submission Date that Met QC Criteria

May 31, 2019

First Posted Date

Jun 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2019

Last Update Posted Date

Jun 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging (MRI) 3 tesla	Device	Functional neuroimaging objectifies the activation of specific areas of the brain	Group exposed to cognitive remediation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Activation of cortical areas	Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barthélémy TOSELLO, PH	Contact	491968300	+33	barthelemy.tosello@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Jean-Olivier ARNAUD, Director	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hôpitaux de Marseille		Marseille		13354	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided