Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083822
Status:
UNKNOWN
Last Update Posted:
2014-09-19
First Post:
2013-12-13
Brief Title:
Cerebral Abnormalities Detected by MRI Realized at the Age of Term and the Emergence of Executive Functions
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Cerebral Abnormalities Detected by MRI Realized at the Age of Term and the Emergence of Executive Functions
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIRMEX
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
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
At the age of 5 years executive functions and neurodevelopmental testing would be realized
600 newborns were recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None