Development of Maternal Voice Recognition in Preterm Neonates

NCT ID: NCT02818595

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infant, Premature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal children

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

Group Type EXPERIMENTAL

electroencephalogram (HR-EEG)

Intervention Type DEVICE

Near Infra Red Spectroscopy (NIRS)

Intervention Type DEVICE

Abnormal children

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

Group Type EXPERIMENTAL

electroencephalogram (HR-EEG)

Intervention Type DEVICE

Near Infra Red Spectroscopy (NIRS)

Intervention Type DEVICE

Interventions

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electroencephalogram (HR-EEG)

Intervention Type DEVICE

Near Infra Red Spectroscopy (NIRS)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice WALLOIS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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Beauchemin M, Gonzalez-Frankenberger B, Tremblay J, Vannasing P, Martinez-Montes E, Belin P, Beland R, Francoeur D, Carceller AM, Wallois F, Lassonde M. Mother and stranger: an electrophysiological study of voice processing in newborns. Cereb Cortex. 2011 Aug;21(8):1705-11. doi: 10.1093/cercor/bhq242. Epub 2010 Dec 13.

Reference Type RESULT
PMID: 21149849 (View on PubMed)

Other Identifiers

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PI11-DR-WALLOIS

Identifier Type: -

Identifier Source: org_study_id

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