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

September 18, 2014 updated by: University Hospital, Tours

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49 000
        • Service de Neurologie Pédiatrique
      • Bordeaux, France, 33 000
        • Service de Néonatologie
      • Caen, France, 14 000
        • Service de Néonatologie
      • Grenoble, France, 38 000
        • Médecine Néonatale et Réanimation Pédiatrique
      • Kremlin Bicêtre, France, 94275
        • Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
      • Lille, France, 59 000
        • Service de Néonatologie
      • Marseille, France, 13 000
        • Médecine Infantile - Néonatologie - Périnatologie
      • Marseille, France, 13 000
        • Service de Néonatalogie
      • Nancy, France, 54000
        • Service de Néonatologie
      • Nantes, France, 44000
        • Service de Néonatologie
      • Paris, France, 75 000
        • Réanimation néonatale et Néonatologie
      • Reims, France, 51 000
        • Service de Réanimation, Néonatologie
      • Rennes, France, 35000
        • Service de Néonatologie
      • Rouen, France, 76000
        • Service de Pédiatrie néonatale et réanimation
      • Tours, France, 37 000
        • Service de Réanimation pédiatrique, Néonatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI assessment
Procedure: term MRI, executive EF functions testing
An MRI will be realized at term born between 25 and 32 weeks GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Time Frame: During the 5 years follow up
During the 5 years follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Perinatal risk factors and cerebral lesions as assessed on MRI
Time Frame: During the 5 years follow up
During the 5 years follow up
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
Time Frame: During the 5 years follow up
During the 5 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRN11-ES / EPIRMEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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