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Completed

NCT Number: NCT02826733

Evaluation of the Implementation of the Hemispheric Dominance During Development

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.

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Key information

Conditions

Neuroimaging

Age range

0 day–10 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Electroencephalogram (EEG)

Device

Near Infra Red Spectroscopy (NIRS)

Device

Magnetic Resonance Imaging (MRI)

Device

Primary outcomes

  1. discrimination of language - EEG

    Time frame: 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

  2. discrimination of language - NIRS

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: HEMISPHERENOR

Important dates

Study start
2009
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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