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

Primary Purpose

Premature Baby 25 to 32 Weeks

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
term MRI, executive EF functions testing
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Baby 25 to 32 Weeks focused on measuring premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age

Eligibility Criteria

25 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Neurologie Pédiatrique
  • Service de Néonatologie
  • Service de Néonatologie
  • Médecine Néonatale et Réanimation Pédiatrique
  • Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
  • Service de Néonatologie
  • Médecine Infantile - Néonatologie - Périnatologie
  • Service de Néonatalogie
  • Service de Néonatologie
  • Service de Néonatologie
  • Réanimation néonatale et Néonatologie
  • Service de Réanimation, Néonatologie
  • Service de Néonatologie
  • Service de Pédiatrie Néonatale et Réanimation
  • Service de Réanimation pédiatrique, Néonatologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI assessment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perinatal risk factors and cerebral lesions as assessed on MRI
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age

Full Information

First Posted
December 13, 2013
Last Updated
September 18, 2014
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02083822
Brief Title
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
Acronym
EPIRMEX
Official Title
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Baby 25 to 32 Weeks
Keywords
premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI assessment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
term MRI, executive EF functions testing
Intervention Description
An MRI will be realized at term born between 25 and 32 weeks GA
Primary Outcome Measure Information:
Title
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Time Frame
During the 5 years follow up
Secondary Outcome Measure Information:
Title
Perinatal risk factors and cerebral lesions as assessed on MRI
Time Frame
During the 5 years follow up
Title
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
Time Frame
During the 5 years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Service de Neurologie Pédiatrique
City
Angers
ZIP/Postal Code
49 000
Country
France
Facility Name
Service de Néonatologie
City
Bordeaux
ZIP/Postal Code
33 000
Country
France
Facility Name
Service de Néonatologie
City
Caen
ZIP/Postal Code
14 000
Country
France
Facility Name
Médecine Néonatale et Réanimation Pédiatrique
City
Grenoble
ZIP/Postal Code
38 000
Country
France
Facility Name
Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
City
Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Service de Néonatologie
City
Lille
ZIP/Postal Code
59 000
Country
France
Facility Name
Médecine Infantile - Néonatologie - Périnatologie
City
Marseille
ZIP/Postal Code
13 000
Country
France
Facility Name
Service de Néonatalogie
City
Marseille
ZIP/Postal Code
13 000
Country
France
Facility Name
Service de Néonatologie
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Service de Néonatologie
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Réanimation néonatale et Néonatologie
City
Paris
ZIP/Postal Code
75 000
Country
France
Facility Name
Service de Réanimation, Néonatologie
City
Reims
ZIP/Postal Code
51 000
Country
France
Facility Name
Service de Néonatologie
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Service de Pédiatrie Néonatale et Réanimation
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Service de Réanimation pédiatrique, Néonatologie
City
Tours
ZIP/Postal Code
37 000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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