Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants

EEG Clinical Trial

— Exposition  

Official title:

Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417542
• Other study ID #: PI2021_843_0054
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: May 2029

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Wallois, Pr
• Phone: 03 22 087775
• Email: fabrice.wallois[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Full term neonates between 28 and 40 weeks Gestational Age

Exclusion Criteria:

• Neonates outside the age range

Related Conditions & MeSH terms

• Discrimination
• EEG
• Premature Birth
• Premature Neonates
• Time Perception

Intervention

Other:
• EEG
EEG recording during prematurity or around term
• NIRS
NIRS recording during prematurity or around term

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	Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups		one day
Primary	Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups		one day
Primary	Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups		one day
Primary	variations of the response of the cortical network using High Density Near Infrared Spectroscopy before auditory stimuli between the 5 infant groups		one day
Primary	variations of the response of the cortical network using High Density Near Infrared Spectroscopy during auditory stimuli between the 5 infant groups		one day
Primary	variations of the response of the cortical network using High Density Near Infrared Spectroscopy after auditory stimuli between the 5 infant groups		one day