Development of Maternal Voice Recognition in Preterm Neonates

NCT02818595 | Completed

• 1 other identifier: PI11-DR-WALLOIS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Keywords

voice recognition

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Normal children

EXPERIMENTAL

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

Device: electroencephalogram (HR-EEG); Device: Near Infra Red Spectroscopy (NIRS)

Abnormal children

EXPERIMENTAL

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

Device: electroencephalogram (HR-EEG); Device: Near Infra Red Spectroscopy (NIRS)

Interventions

electroencephalogram (HR-EEG) DEVICE

Abnormal children; Normal children

Near Infra Red Spectroscopy (NIRS) DEVICE

Abnormal children; Normal children

Eligibility Criteria

• Age: 0 Days - 6 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

• 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.

  PMID: 21149849 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Fabrice WALLOIS, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 30, 2016
• Study Start: March 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)