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

June 5, 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 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

240

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 1 day (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • full term neonates between 25 and 36 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
Active Comparator: normal 25-36 gestational week preterm infant
Procedure: 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
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
Experimental: 25-36 gestational week preterm infant with IVH
25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
Procedure: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
Time Frame: at day 0
measure at which age the ability to discriminate time features occurs in premature neonates. For the analysis of discrimination, the investigators will use cluster analysis as implemented in the Matlab Friedtrip toolbox.
at day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
Time Frame: at day 0
variation of the ability to discriminate time features between the IVH and normal preterm groups. For the analysis of time-frequency responses, the investigators will use cluster randomization procedures as implemented in the BESA statistical tools.
at day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Pierre Tourneux, Pr, CHU Amiens
  • Principal Investigator: Ghilda Ghostine, MD, CHU Amiens
  • Principal Investigator: Guy Kongolo, MD, CHU Amiens
  • Principal Investigator: Sabrina Goudjil, MD, CHU Amiens
  • Principal Investigator: Christèle Chazal, MD, CHU Amiens
  • Principal Investigator: Coralie Degorre, MD, CHU Amiens
  • Principal Investigator: Emilie Bourel, MD, CHU Amiens
  • Principal Investigator: Laura Routier, MD, CHU Amiens
  • Principal Investigator: Claire Héberlé, MD, CHU Amiens
  • Principal Investigator: André Léké, MD, CHU 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)

February 1, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2019_843_0041

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

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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