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

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ClinicalTrials.gov Identifier: NCT02083822
Recruitment Status : Unknown
Verified September 2014 by University Hospital, Tours.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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


Condition or disease Intervention/treatment Phase
Premature Baby 25 to 32 Weeks Procedure: term MRI, executive EF functions testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
Study Start Date : June 2011
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   25 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083822


Locations
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France
Service de Neurologie Pédiatrique
Angers, France, 49 000
Service de Néonatologie
Bordeaux, France, 33 000
Service de Néonatologie
Caen, France, 14 000
Médecine Néonatale et Réanimation Pédiatrique
Grenoble, France, 38 000
Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
Kremlin Bicêtre, France, 94275
Service de Néonatologie
Lille, France, 59 000
Médecine Infantile - Néonatologie - Périnatologie
Marseille, France, 13 000
Service de Néonatalogie
Marseille, France, 13 000
Service de Néonatologie
Nancy, France, 54000
Service de Néonatologie
Nantes, France, 44000
Réanimation néonatale et Néonatologie
Paris, France, 75 000
Service de Réanimation, Néonatologie
Reims, France, 51 000
Service de Néonatologie
Rennes, France, 35000
Service de Pédiatrie Néonatale et Réanimation
Rouen, France, 76000
Service de Réanimation pédiatrique, Néonatologie
Tours, France, 37 000
Sponsors and Collaborators
University Hospital, Tours
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02083822    
Other Study ID Numbers: PHRN11-ES / EPIRMEX
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by University Hospital, Tours:
premature baby
MRI : conventional and advanced images
Executive function testing at 5 years of age
Additional relevant MeSH terms:
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Premature Birth
Congenital Abnormalities
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications