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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05417542

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Time Perception Rhythm EEG fNIRS ERP Premature Neonates Discrimination	Other: EEG Other: NIRS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

May 1, 2029

Anticipated Study Completion Date :

May 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exposition I preterm neonates between 28 and 30 wGA Exposition to music during the NICU period	Other: EEG EEG recording during prematurity or around term Other: NIRS NIRS recording during prematurity or around term
Experimental: Exposition II preterm neonates between 32 and 34 wGA Exposition to music during the NICU period	Other: EEG EEG recording during prematurity or around term Other: NIRS NIRS recording during prematurity or around term
Active Comparator: Control I preterm neonates between 28 and 30 wGA	Other: EEG EEG recording during prematurity or around term Other: NIRS NIRS recording during prematurity or around term
Active Comparator: Control II preterm neonates between 32 and 34 wGA	Other: EEG EEG recording during prematurity or around term Other: NIRS NIRS recording during prematurity or around term
Active Comparator: Control III preterm neonates between 36 and 40 wGA	Other: EEG EEG recording during prematurity or around term Other: NIRS NIRS recording during prematurity or around term

Outcome Measures

Primary Outcome Measures

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