Trials / Unknown
UnknownNCT02083822
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- University Hospital, Tours · Academic / Other
- Sex
- All
- Age
- 25 Weeks – 32 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | term MRI, executive EF functions testing | An MRI will be realized at term born between 25 and 32 weeks GA |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2016-09-01
- Completion
- 2017-09-01
- First posted
- 2014-03-11
- Last updated
- 2014-09-19
Locations
15 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02083822. Inclusion in this directory is not an endorsement.