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

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Premature Baby 25 to 32 Weeks

Treatments

Procedure: term MRI, executive EF functions testing

Study type

Interventional

Funder types

Other

Identifiers

NCT02083822
PHRN11-ES / EPIRMEX

Details and patient eligibility

About

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

Full 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.

Enrollment

600 patients

Sex

All

Ages

25 to 32 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

MRI assessment
Experimental group
Treatment:
Procedure: term MRI, executive EF functions testing

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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