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

Not Applicable

• Conditions: Premature Baby 25 to 32 Weeks
• Interventions: Procedure: term MRI, executive EF functions testing

• Registration Number: NCT02083822
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI assessment	term MRI, executive EF functions testing	-

Primary Outcome Measures

Name	Time	Method
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings	During the 5 years follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Service de Néonatologie; 🇫🇷 Rennes, France

Service de Neurologie Pédiatrique; 🇫🇷 Angers, France

Médecine Néonatale et Réanimation Pédiatrique; 🇫🇷 Grenoble, France

Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE; 🇫🇷 Kremlin Bicêtre, France

Médecine Infantile - Néonatologie - Périnatologie; 🇫🇷 Marseille, France

Service de Néonatalogie; 🇫🇷 Marseille, France

Réanimation néonatale et Néonatologie; 🇫🇷 Paris, France

Service de Réanimation, Néonatologie; 🇫🇷 Reims, France

Service de Pédiatrie Néonatale et Réanimation; 🇫🇷 Rouen, France

Service de Réanimation pédiatrique, Néonatologie; 🇫🇷 Tours, France