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Clinical Trials/NCT02083822
NCT02083822
Unknown
N/A

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

University Hospital, Tours10 sites in 1 country600 target enrollmentJune 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Baby 25 to 32 Weeks
Sponsor
University Hospital, Tours
Enrollment
600
Locations
10
Primary Endpoint
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
September 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Perinatal risk factors and cerebral lesions as assessed on MRI(During the 5 years follow up)
  • Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age(During the 5 years follow up)

Study Sites (10)

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