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Completed

NCT Number: NCT02083822

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

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

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Key information

Conditions

Premature Baby 25 to 32 Weeks Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

25 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie Pédiatrique, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

term MRI, executive EF functions testing

Procedure

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

Primary outcomes

  1. Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings

    Time frame: During the 5 years follow up

Secondary outcomes

  1. Perinatal risk factors and cerebral lesions as assessed on MRI

    Time frame: During the 5 years follow up

  2. Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age

    Time frame: During the 5 years follow up

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: EPIRMEX

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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