Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood

NCT ID: NCT04270734

Last Updated: 2025-06-10

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2027-02-28

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 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.

Detailed Description

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Neurodevelopmental disorders may be related to functional or structural disruption of the neuronal network organization at an early stage or later in the course of development. The disruption of the initial set-up could partially explain the prevalence of neurodevelopmental risks due to prematurity. The development period between 25 and 33 wGA corresponds to the period of very great prematurity and represents a key period of neurodevelopment in terms of structural and functional establishment of neuronal networks. One way to address the functionality of the neuronal networks is to evaluate the neural response to the exogenous stimuli and to interpret the mechanisms and the developmental status of the network in their ability to develop appropriate responses.

Conditions

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Time Perception EEG 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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normal 25-36 gestational week preterm infant

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type PROCEDURE

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed

NIRS

Intervention Type PROCEDURE

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed

25-36 gestational week preterm infant with IVH

25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)

Group Type EXPERIMENTAL

EEG

Intervention Type PROCEDURE

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed

NIRS

Intervention Type PROCEDURE

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed

Interventions

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EEG

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed

Intervention Type PROCEDURE

NIRS

Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria

* Neonates outside the age range
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

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

Principal Investigators

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Ghilda Ghostine, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Guy Kongolo, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Sabrina Goudjil, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

André Léké, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Christèle Chazal, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Pierre Tourneux, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Coralie Degorre, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Emilie Bourel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Laura Routier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Claire Héberlé, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

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

(33)322087775

Facility Contacts

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Fabrice Wallois, Pr

Role: primary

(33)322087775

Guy Kongolo, Pr

Role: backup

(33)322455877

Other Identifiers

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PI2019_843_0041

Identifier Type: -

Identifier Source: org_study_id

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