Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very … (NCT06055062) | Clinical Trial Compass
UnknownNot Applicable
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old
39 participantsStarted 2023-10
Plain-language 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).
Who can participate
Age range
66 Months – 66 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.