Evaluation of the Implementation of the Hemispheric Dominance During Development (HEMISPHERENOR)

Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuroimaging
• Intervention / Treatment: Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI); Device: Electroencephalogram (EEG)

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The inclusion of patients in the study will be conducted in the intensive care unit and neonatal intensive care CHU Amiens .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal; 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	Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI); Device: Electroencephalogram (EEG)
cerebral neurological disease; 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	Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI); Device: Electroencephalogram (EEG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discrimination of language - EEG	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	Day 0
discrimination of language - NIRS	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	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2009
• Primary Completion (ACTUAL): November 3, 2021
• Study Completion (ANTICIPATED): November 3, 2024

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: preterm infants; term infants; hemispheric dominance
• Other Study ID Numbers: PI08-DR-WALLOIS