Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
EPIRMEX
1 other identifier
interventional
600
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2018
CompletedJune 17, 2026
June 1, 2026
6.5 years
December 13, 2013
June 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
During the 5 years follow up
Secondary Outcomes (2)
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
Study Arms (1)
MRI assessment
EXPERIMENTALInterventions
An MRI will be realized at term born between 25 and 32 weeks GA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Infants with congenital abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Service de Neurologie Pédiatrique
Angers, 49 000, France
Service de Néonatologie
Bordeaux, 33 000, France
Service de Néonatologie
Caen, 14 000, France
Médecine Néonatale et Réanimation Pédiatrique
Grenoble, 38 000, France
Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
Le Kremlin-Bicêtre, 94275, France
Service de Néonatologie
Lille, 59 000, France
Médecine Infantile - Néonatologie - Périnatologie
Marseille, 13 000, France
Service de Néonatalogie
Marseille, 13 000, France
Service de Néonatologie
Nancy, 54000, France
Service de Néonatologie
Nantes, 44000, France
Réanimation néonatale et Néonatologie
Paris, 75 000, France
Service de Réanimation, Néonatologie
Reims, 51 000, France
Service de Néonatologie
Rennes, 35000, France
Service de Pédiatrie Néonatale et Réanimation
Rouen, 76000, France
Service de Réanimation pédiatrique, Néonatologie
Tours, 37 000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2013
First Posted
March 11, 2014
Study Start
June 30, 2011
Primary Completion
January 8, 2018
Study Completion
January 8, 2018
Last Updated
June 17, 2026
Record last verified: 2026-06