Cerebral Abnormalities Detected by MRI, Realized at the A... | NCT02083822

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2011Actual

Primary Completion Date

Jan 8, 2018Actual

Completion Date

Jan 8, 2018Actual

First Submitted Date

Dec 13, 2013

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 11, 2014Estimated

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

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.

These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.

Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.

The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome

Detailed Description

An MRI would be realized between 39 and 41 GA

At the age of 5 years, executive functions and neurodevelopmental testing would be realized.

600 newborns were recruited.

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI assessment	Experimental		Procedure: term MRI, executive EF functions testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
term MRI, executive EF functions testing	Procedure	An MRI will be realized at term born between 25 and 32 weeks GA	MRI assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings		During the 5 years follow up

Secondary Outcomes

Measure	Description	Time Frame
Perinatal risk factors and cerebral lesions as assessed on MRI		During the 5 years follow up
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age		During the 5 years follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Infants who were :

born between 25 and 32 WGA
hospitalized in a neonatology service which participate to the present study
included in EPIPAGE 2 follow-up study
infants whose parents had signed the consent agreement and benefit from national health insurance

Exclusion Criteria

Infants with congenital abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Weeks

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neurologie Pédiatrique		Angers		49 000	France
Service de Néonatologie

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases