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

Study Overview
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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.

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

Conditions
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Premature Baby 25 to 32 Weeks

Intervention / Treatment
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* Procedure: term MRI, executive EF functions testing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI assessment<br> | Procedure: term MRI, executive EF functions testing<br>* An MRI will be realized at term born between 25 and 32 weeks GA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age