Premature Baby 25 to 32 Weeks Clinical Trial
— EPIRMEXOfficial title:
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
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
| Status | Active, not recruiting |
| Enrollment | 600 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Weeks to 32 Weeks |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Neurologie Pédiatrique | Angers | |
| France | Service de Néonatologie | Bordeaux | |
| France | Service de Néonatologie | Caen | |
| France | Médecine Néonatale et Réanimation Pédiatrique | Grenoble | |
| France | Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE | Kremlin Bicêtre | |
| France | Service de Néonatologie | Lille | |
| France | Médecine Infantile - Néonatologie - Périnatologie | Marseille | |
| France | Service de Néonatalogie | Marseille | |
| France | Service de Néonatologie | Nancy | |
| France | Service de Néonatologie | Nantes | |
| France | Réanimation néonatale et Néonatologie | Paris | |
| France | Service de Réanimation, Néonatologie | Reims | |
| France | Service de Néonatologie | Rennes | |
| France | Service de Pédiatrie Néonatale et Réanimation | Rouen | |
| France | Service de Réanimation pédiatrique, Néonatologie | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings | During the 5 years follow up | No | |
| Secondary | Perinatal risk factors and cerebral lesions as assessed on MRI | During the 5 years follow up | No | |
| Secondary | Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age | During the 5 years follow up | No |