Evaluation of the Implementation of the Hemispheric Dominance During Development

Neuroimaging Clinical Trial

— HEMISPHERENOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02826733
• Other study ID #: PI08-DR-WALLOIS
• Status: Active, not recruiting
• Start date: November 4, 2009
• Est. completion date: November 3, 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: November 3, 2024
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 10 Weeks

Eligibility

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 .

Related Conditions & MeSH terms

• Neuroimaging

Intervention

Device:
• Electroencephalogram (EEG)

• Near Infra Red Spectroscopy (NIRS)

• magnetic resonance imaging (MRI)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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