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临床试验/NCT06055062
NCT06055062尚未招募不适用

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 个研究点目标入组 39 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
39
主要终点
neurodevelopmental development

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
66 Months 至 66 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

neurodevelopmental development

时间窗: 1 month

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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

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