Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Exposition
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedStudy Start
First participant enrolled
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
May 28, 2025
May 1, 2025
6.9 years
May 31, 2022
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (5)
Exposition I
EXPERIMENTALpreterm neonates between 28 and 30 wGA Exposition to music during the NICU period
Exposition II
EXPERIMENTALpreterm neonates between 32 and 34 wGA Exposition to music during the NICU period
Control I
ACTIVE COMPARATORpreterm neonates between 28 and 30 wGA
Control II
ACTIVE COMPARATORpreterm neonates between 32 and 34 wGA
Control III
ACTIVE COMPARATORpreterm neonates between 36 and 40 wGA
Interventions
Eligibility Criteria
You may qualify if:
- Full term neonates between 28 and 40 weeks Gestational Age
You may not qualify if:
- Neonates outside the age range
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 14, 2022
Study Start
May 31, 2022
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
May 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share