Evaluation of the Implementation of the Hemispheric Dominance During Development

Active, not recruiting

• Conditions: Neuroimaging
• Interventions: Device: Electroencephalogram (EEG); Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI)

• Registration Number: NCT02826733
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning?

The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Primary Completion: 2021-11-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Completion: 2024-11-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks.
• normal group of children : A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).
• Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion Criteria

• severe congenital malformation
• Any refusal of a parent .
• Children with severe impairment of the general condition and vital functions
• Children with dermatitis of the face or scalp
• Children treated with ventilation High Frequency (HFO )
• Presence of intravenous access on the scalp ( preventing the realization of the ETF , EEG or NIRS .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	magnetic resonance imaging (MRI)	Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI). EEG NIRS MRI
Normal	Electroencephalogram (EEG)	Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI). EEG NIRS MRI
cerebral neurological disease	Near Infra Red Spectroscopy (NIRS)	Group of children meeting the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological (ETF , Scanner, MRI) The children present either convulsions or a cerebrovascular accident or a neurological pain . Each condition being verified by a pathological electroencephalogram . EEG NIRS MRI
cerebral neurological disease	Electroencephalogram (EEG)	Group of children meeting the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological (ETF , Scanner, MRI) The children present either convulsions or a cerebrovascular accident or a neurological pain . Each condition being verified by a pathological electroencephalogram . EEG NIRS MRI
Normal	Near Infra Red Spectroscopy (NIRS)	Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI). EEG NIRS MRI
cerebral neurological disease	magnetic resonance imaging (MRI)	Group of children meeting the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological (ETF , Scanner, MRI) The children present either convulsions or a cerebrovascular accident or a neurological pain . Each condition being verified by a pathological electroencephalogram . EEG NIRS MRI

Primary Outcome Measures

Name	Time	Method
discrimination of language - EEG	Day 0	Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the EEG signals
discrimination of language - NIRS	Day 0	Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the NIRS signals

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France