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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083822
Acronym
EPIRMEX
Enrollment
600
Registered
2014-03-11
Start date
2011-06-30
Completion date
2018-01-08
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Baby 25 to 32 Weeks

Keywords

premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age

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.

Interventions

PROCEDUREterm MRI, executive EF functions testing

An MRI will be realized at term born between 25 and 32 weeks GA

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Weeks to 32 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagingsDuring the 5 years follow up

Secondary

MeasureTime frame
Perinatal risk factors and cerebral lesions as assessed on MRIDuring the 5 years follow up
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of ageDuring the 5 years follow up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026