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Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old (Spectro5-5)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Not yet enrolling

Conditions

Preterm Birth

Study type

Observational

Funder types

Other

Identifiers

NCT06055062
RCAPHM22_0508

Details and patient eligibility

About

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).

Enrollment

39 estimated patients

Sex

All

Ages

66 to 66 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Central trial contact

Barthélémy Tosello, Pr

Data sourced from clinicaltrials.gov

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