Development of Maternal Voice Recognition in Preterm Neonates

Infant, Premature Clinical Trial

— PREMAVOIX  

Official title:

Development of Maternal Voice Recognition in Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818595
• Other study ID #: PI11-DR-WALLOIS
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infant, Premature

Intervention

Device:
• electroencephalogram (HR-EEG)

• Near Infra Red Spectroscopy (NIRS)

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	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