Skip to main content
OpenTrials
Completed

NCT Number: NCT02818595

Development of Maternal Voice Recognition in Preterm Neonates

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 day–6 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroencephalogram (HR-EEG)

Device

Near Infra Red Spectroscopy (NIRS)

Device

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PREMAVOIX

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.