Overview

This trial is active, not recruiting.

Condition neuroimaging
Treatments electroencephalogram (eeg), near infra red spectroscopy (nirs), magnetic resonance imaging (mri)
Sponsor Centre Hospitalier Universitaire, Amiens
Start date September 2008
End date February 2018
Trial size 40 participants
Trial identifier NCT02826733, PI08-DR-WALLOIS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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
electroencephalogram (eeg)
near infra red spectroscopy (nirs)
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
electroencephalogram (eeg)
near infra red spectroscopy (nirs)
magnetic resonance imaging (mri)

Primary Outcomes

Measure
discrimination of language - EEG
time frame: Day 0
discrimination of language - NIRS
time frame: Day 0

Eligibility Criteria

Male or female participants up to 10 weeks old.

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 .

Additional Information

Official title Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term
Principal investigator Fabrice WALLOIS, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.