Trials / Unknown
UnknownNCT06055062
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old: EPIPAGE2 and EPIRMEX Cohort Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 66 Months – 66 Months
- Healthy volunteers
- Not accepted
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 Creatine(Cre), 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).
Conditions
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2023-09-26
- Last updated
- 2023-09-26
Source: ClinicalTrials.gov record NCT06055062. Inclusion in this directory is not an endorsement.