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

Primary Purpose

Time Perception, Rhythm, EEG

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG
NIRS
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Time Perception focused on measuring Time perception, rhythm, EEG, fNIRS, ERP, Premature neonates, Discrimination

Eligibility Criteria

0 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Full term neonates between 28 and 40 weeks Gestational Age

Exclusion Criteria:

  • Neonates outside the age range

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exposition I

Exposition II

Control I

Control II

Control III

Arm Description

preterm neonates between 28 and 30 wGA Exposition to music during the NICU period

preterm neonates between 32 and 34 wGA Exposition to music during the NICU period

preterm neonates between 28 and 30 wGA

preterm neonates between 32 and 34 wGA

preterm neonates between 36 and 40 wGA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
June 9, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05417542
Brief Title
Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Acronym
Exposition
Official Title
Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
May 2029 (Anticipated)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Perception, Rhythm, EEG, fNIRS, ERP, Premature Neonates, Discrimination
Keywords
Time perception, rhythm, EEG, fNIRS, ERP, Premature neonates, Discrimination

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposition I
Arm Type
Experimental
Arm Description
preterm neonates between 28 and 30 wGA Exposition to music during the NICU period
Arm Title
Exposition II
Arm Type
Experimental
Arm Description
preterm neonates between 32 and 34 wGA Exposition to music during the NICU period
Arm Title
Control I
Arm Type
Active Comparator
Arm Description
preterm neonates between 28 and 30 wGA
Arm Title
Control II
Arm Type
Active Comparator
Arm Description
preterm neonates between 32 and 34 wGA
Arm Title
Control III
Arm Type
Active Comparator
Arm Description
preterm neonates between 36 and 40 wGA
Intervention Type
Other
Intervention Name(s)
EEG
Intervention Description
EEG recording during prematurity or around term
Intervention Type
Other
Intervention Name(s)
NIRS
Intervention Description
NIRS recording during prematurity or around term
Primary Outcome Measure Information:
Title
Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups
Time Frame
one day
Title
Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups
Time Frame
one day
Title
Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups
Time Frame
one day
Title
variations of the response of the cortical network using High Density Near Infrared Spectroscopy before auditory stimuli between the 5 infant groups
Time Frame
one day
Title
variations of the response of the cortical network using High Density Near Infrared Spectroscopy during auditory stimuli between the 5 infant groups
Time Frame
one day
Title
variations of the response of the cortical network using High Density Near Infrared Spectroscopy after auditory stimuli between the 5 infant groups
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full term neonates between 28 and 40 weeks Gestational Age Exclusion Criteria: Neonates outside the age range
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Wallois, Pr
Phone
03 22 087775
Email
fabrice.wallois@u-picardie.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice WALLOIS, MD, PhD
Phone
+33 3 22 08 77 77
Email
wallois.fabrice@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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