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Clinical Trials/NCT06055062
NCT06055062
Not yet recruiting
Not Applicable

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

Assistance Publique Hopitaux De Marseille0 sites39 target enrollmentOctober 2023
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
39
Primary Endpoint
neurodevelopmental development
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria form EPIPAGE2 and EPIRMEX
  • Children who underwent spectroscopy with regions of interest analyzed: periventricular zone, gray nuclei, brainstem.
  • Children who received a complete cognitive assessment in EPIRMEX (integrated assessment identical to that planned in EPIPAGE2) at age 5 ½.
  • Non-inclusion Criteria:
  • Children with severe karyotype abnormalities.
  • Children with central nervous system malformations diagnosed antenatally or on neonatal tests
  • Children with severe cerebral palsy or major neurosensory (blindness, profound deafness...) not allowing children to take the tests scheduled at age 5 ½.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

neurodevelopmental development

Time Frame: 1 month

neurodevelopmental development will be judged on the presence of neurodevelopmental disorders as follows : * severe or moderate disorders * mild disorders * absence of disorders

Secondary Outcomes

  • Schooling(1 month)
  • Explored disabilities(1 month)

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