Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055062
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-20
Brief Title:
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 55-years-old
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 55-years-old EPIPAGE2 and EPIRMEX Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Spectro5-5
Brief Summary:
Background Compared to term-born peers very preterm children generally perform poorly in executive functions with a significant impact on learning at school and quality of life These EF deficits are related to microstructural abnormalities in white matter and subcortical brain structure
Objective To investigate if an alteration of cerebral metabolism in very premature at term corrected-age correlates to executive dysfunctions at school age
Design setting patients Very preterm patients eligible for Epirmex underwent cerebral Magnetic Resonance Imaging at term-equivalent age and 1H-MRS using a monovoxel technique The volumes of interest were the posterior periventricular white matter zone and the basal ganglia and thalamus The ratios of N Acetyl Aspartate NAA to Choline cho NAA to CreatineCre Cho to Cr and Lac Lactate to Cr were calculated
Main outcome measures Survival at 5 ½ years with or without neurodevelopmental disabilities composed of cerebral palsy visual hearing cognitive deficiency behavioral difficulties or developmental coordination disorders were described The executive functions were assessed using two indices from the Wechsler Intelligence Scale measured in the EPIPAGE 2 cohort at age five-and one-half years the Working Memory Index WMI and the Fluid Reasoning Index FRI
Objective To investigate if an alteration of cerebral metabolism in very premature at term corrected-age correlates to executive dysfunctions at school age
Design setting patients Very preterm patients eligible for Epirmex underwent cerebral Magnetic Resonance Imaging at term-equivalent age and 1H-MRS using a monovoxel technique The volumes of interest were the posterior periventricular white matter zone and the basal ganglia and thalamus The ratios of N Acetyl Aspartate NAA to Choline cho NAA to CreatineCre Cho to Cr and Lac Lactate to Cr were calculated
Main outcome measures Survival at 5 ½ years with or without neurodevelopmental disabilities composed of cerebral palsy visual hearing cognitive deficiency behavioral difficulties or developmental coordination disorders were described The executive functions were assessed using two indices from the Wechsler Intelligence Scale measured in the EPIPAGE 2 cohort at age five-and one-half years the Working Memory Index WMI and the Fluid Reasoning Index FRI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None