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

May 22, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Full term neonates between 28 and 40 weeks Gestational Age

Exclusion Criteria:

  • Neonates outside the age range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups
Time Frame: one day
one day
Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups
Time Frame: one day
one day
Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups
Time Frame: one day
one day
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
one day
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
one day
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
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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