Infant, Premature Clinical Trial
— PREMAVOIXOfficial title:
Development of Maternal Voice Recognition in Preterm Neonates
NCT number | NCT02818595 |
Other study ID # | PI11-DR-WALLOIS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | June 2017 |
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Many cognitive functions in humans are based on asymmetrical brain networks. For example, in
most adults, the language is essentially processed by the left hemisphere, while other
auditory functions, such as voice recognition, tend to be processed by the right hemisphere.
Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the
presence of anatomical and functional asymmetries by the first months of life. What are the
causes of these asymmetries? How do they develop? Are they necessary for functioning or
effective learning?
This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif
El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of
development at which hemispheric dominance for voice recognition is first observed and to
identify the brain structure involved in preterm neonates whose sound environment is usually
very different from that of the foetus. The impact of this environment on the infant's brain
development and early learning will be evaluated.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Days |
Eligibility |
Inclusion Criteria: - The distribution of children in the different groups of infants included in the study will be validated at the time of the acquisitions. - 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: About history: - All children with severe congenital malformation Regarding the study period; - 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 and NIRS |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference in amplitude | The difference in amplitude of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response | 10 weeks | |
Primary | The difference in latency | The difference in latency of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response | 10 weeks |
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