Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions

NCT ID: NCT02083822

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Premature Baby 25 to 32 Weeks

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI assessment

Group Type EXPERIMENTAL

term MRI, executive EF functions testing

Intervention Type PROCEDURE

An MRI will be realized at term born between 25 and 32 weeks GA

Interventions

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term MRI, executive EF functions testing

An MRI will be realized at term born between 25 and 32 weeks GA

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Neurologie Pédiatrique

Angers, , France

Site Status

Service de Néonatologie

Bordeaux, , France

Site Status

Service de Néonatologie

Caen, , France

Site Status

Médecine Néonatale et Réanimation Pédiatrique

Grenoble, , France

Site Status

Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE

Le Kremlin-Bicêtre, , France

Site Status

Service de Néonatologie

Lille, , France

Site Status

Médecine Infantile - Néonatologie - Périnatologie

Marseille, , France

Site Status

Service de Néonatalogie

Marseille, , France

Site Status

Service de Néonatologie

Nancy, , France

Site Status

Service de Néonatologie

Nantes, , France

Site Status

Réanimation néonatale et Néonatologie

Paris, , France

Site Status

Service de Réanimation, Néonatologie

Reims, , France

Site Status

Service de Néonatologie

Rennes, , France

Site Status

Service de Pédiatrie Néonatale et Réanimation

Rouen, , France

Site Status

Service de Réanimation pédiatrique, Néonatologie

Tours, , France

Site Status

Countries

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France

Other Identifiers

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PHRN11-ES / EPIRMEX

Identifier Type: -

Identifier Source: org_study_id

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