Clinical trial NCT02083822: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
Official title: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Baby 25 to 32 Weeks
Keywords: premature baby
MRI : conventional and advanced images
Executive function testing at 5 years of age
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 600
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
timeFrame: During the 5 years follow up
Secondary outcomes:
measure: Perinatal risk factors and cerebral lesions as assessed on MRI
timeFrame: During the 5 years follow up
measure: Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
timeFrame: During the 5 years follow up
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Neurologie Pédiatrique
city: Bordeaux
country: France
facility: Service de Néonatologie
city: Caen
country: France
facility: Service de Néonatologie
city: Grenoble
country: France
facility: Médecine Néonatale et Réanimation Pédiatrique
city: Kremlin Bicêtre
country: France
facility: Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
city: Lille
country: France
facility: Service de Néonatologie
city: Marseille
country: France
facility: Médecine Infantile - Néonatologie - Périnatologie
city: Marseille
country: France
facility: Service de Néonatalogie
city: Nancy
country: France
facility: Service de Néonatologie
city: Nantes
country: France
facility: Service de Néonatologie
city: Paris
country: France
facility: Réanimation néonatale et Néonatologie
city: Reims
country: France
facility: Service de Réanimation, Néonatologie
city: Rennes
country: France
facility: Service de Néonatologie
city: Rouen
country: France
facility: Service de Pédiatrie Néonatale et Réanimation
city: Tours
country: France
facility: Service de Réanimation pédiatrique, Néonatologie
Study officials:
References: