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Clinical Trials/NCT02818595
NCT02818595CompletedNot Applicable

Development of Maternal Voice Recognition in Preterm Neonates

Centre Hospitalier Universitaire, Amiens1 site in 1 country22 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
The difference in amplitude

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
0 Days to 6 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Normal children

Experimental

Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological

Intervention: electroencephalogram (HR-EEG) (Device)

Normal children

Experimental

Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological

Intervention: Near Infra Red Spectroscopy (NIRS) (Device)

Abnormal children

Experimental

Every child meet the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological as intraventricular hemorrhage .

Intervention: electroencephalogram (HR-EEG) (Device)

Abnormal children

Experimental

Every child meet the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological as intraventricular hemorrhage .

Intervention: Near Infra Red Spectroscopy (NIRS) (Device)

Outcomes

Primary Outcomes

The difference in amplitude

Time Frame: 10 weeks

The difference in amplitude of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response

The difference in latency

Time Frame: 10 weeks

The difference in latency of the electrical hemodynamic responses to stimuli depending on the conditions, which corresponds to the evoked potential mismatch Response

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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