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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06055062
Collaborator
(none)
39
2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    39 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. neurodevelopmental development [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 Outcome Measures

    1. Explored disabilities [1 month]

      Explored disabilities will be classified as follows : motor disabilities cognitive disabilites sensory disabilities behavioral disorders

    2. Schooling [1 month]

      Schooling will be judged on the following criteria: type of establishment, specific assistance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    66 Months to 66 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique Hopitaux De Marseille

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique Hopitaux De Marseille
    ClinicalTrials.gov Identifier:
    NCT06055062
    Other Study ID Numbers:
    • RCAPHM22_0508
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2023