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

NCT ID: NCT05417542

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2029-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Time Perception Rhythm EEG fNIRS ERP Premature Neonates Discrimination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exposition I

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

Group Type EXPERIMENTAL

EEG

Intervention Type OTHER

EEG recording during prematurity or around term

NIRS

Intervention Type OTHER

NIRS recording during prematurity or around term

Exposition II

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

Group Type EXPERIMENTAL

EEG

Intervention Type OTHER

EEG recording during prematurity or around term

NIRS

Intervention Type OTHER

NIRS recording during prematurity or around term

Control I

preterm neonates between 28 and 30 wGA

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type OTHER

EEG recording during prematurity or around term

NIRS

Intervention Type OTHER

NIRS recording during prematurity or around term

Control II

preterm neonates between 32 and 34 wGA

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type OTHER

EEG recording during prematurity or around term

NIRS

Intervention Type OTHER

NIRS recording during prematurity or around term

Control III

preterm neonates between 36 and 40 wGA

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type OTHER

EEG recording during prematurity or around term

NIRS

Intervention Type OTHER

NIRS recording during prematurity or around term

Interventions

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EEG

EEG recording during prematurity or around term

Intervention Type OTHER

NIRS

NIRS recording during prematurity or around term

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Full term neonates between 28 and 40 weeks Gestational Age

Exclusion Criteria

* Neonates outside the age range
Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fabrice Wallois, Pr

Role: CONTACT

03 22 087775

Facility Contacts

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Fabrice WALLOIS, MD, PhD

Role: primary

+33 3 22 08 77 77

Other Identifiers

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PI2021_843_0054

Identifier Type: -

Identifier Source: org_study_id

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