- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02851537
Magnetic Resonance Spectroscopy at Term-equivalent Age and Executive Functions at 5 Years of Age Corrected in Very Preterm Infants (EPIRMEX)
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective cohort study on a subsample of children born prematurely (before 33 weeks of gestation (SA) otherwise included in the national cohort EPIPAGE 2 and included in epirmex and who enjoys a spectrosocpie. This research project proposed in the framework of the AORC as ancillary study EPIPAGE 2 -EPIRMEX therefore focuses on spectroIRM voluntarily at the age of term (39-41 SA), and more specifically the emergence executive functions to 5 years EPIRMEX main objective of the study. the application of our project to this tender is requested by the PACA region due to the high rate spectroIRM performed by our area (about 75%) and strong involvement of Dr. C. Gire in EPIPAGE 2 and EPIRMEX. However, only neuropsychological assessments FE 5 years testing sub-cities will be funded EPIPAGE 2. The specific aspect of our study is not funded EPIPAGE 2.
The children received conventional MRI at the age of term (39-41 SA), supplemented by specific sequences for single voxel analysis in microstructural analysis (white matter, basal ganglia and brainstem), short echo and echo time consuming. The study of the spectra will be done quantitatively by CEMEREM laboratory - UMR 6612 CNRS / Université de la Méditerranée / Division of Medical Imaging (Pr Guye).
The relevance of the project was its ability to include quality as 550 MRI were performed, including 120 MRI spectrometer can be analyzed.
These children were assessed within 2 EPIPAGE the corrected age of 2 years, 3 years (EPIRMEX) and 5 years (2 + EPIPAGE EPIRMEX). The balance sheet under 5 years in EPIRMEX is evaluating a comprehensive intellectual efficiency WPPSI III, some elements of the NEPSY and the figure of REY.
So magnetic resonance spectroscopy may provide additional diagnostic value to cranial ultrasound and MRI in infants.
The main objective is to assess the relation between the cerebral MRS at term-equivalent age of very preterm infants and the executive functions at the age of 5 years corrected.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Barthelemy TOSELLO
- Phone Number: 0645918286
- Email: barthelemy.tosello@ap-hm.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Preterm infants born between 26+ 0d and 32 SA + 6d.
- Children included in the study EPIPAGE2, and EPIRMEX and has received spectroscopy.
- Regions of interest analyzed: periventricular area, basal ganglia, brain stem.
- Who has full cognitive assessment in epirmex to 5 years.
Exclusion Criteria:
- Children with severe chromosomal anomaly.
- Children with central nervous system malformation diagnosed prenatally or on examinations in the neonatal period (transfontanellaire ultrasound and/or MRI).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of the executive dysfunction
Time Frame: one day
|
NEPSY score <-1 DS is <8 (required) it is a tool to assess the neuropsychological development of children of preschool and school age (3 to 12 years)
|
one day
|
intellectual efficiency
Time Frame: one day
|
Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
|
one day
|
perceptual organization and memory
Time Frame: one day
|
figure of REY is a short test of perceptual organization and memory.
The figure of Rey is called abnormal for a copy <10th percentile.
|
one day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-17
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