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

Preterm Birth Clinical Trial

— Spectro5-5  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055062
• Other study ID #: RCAPHM22_0508
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Barthélémy Tosello, Pr
• Phone: +33(0)491964822
• Email: barthelemy.tosello[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Months to 66 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurodevelopmental development	neurodevelopmental development will be judged on the presence of neurodevelopmental disorders as follows : severe or moderate disorders; mild disorders; absence of disorders	1 month
Secondary	Explored disabilities	Explored disabilities will be classified as follows : motor disabilities; cognitive disabilites; sensory disabilities; behavioral disorders	1 month
Secondary	Schooling	Schooling will be judged on the following criteria: type of establishment, specific assistance.	1 month