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

Primary Purpose

Time Perception, EEG, Premature Neonates

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG
NIRS
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Time Perception focused on measuring time perception, rhythm, EEG, fNIRS, ERP, premature neonates, discrimination

Eligibility Criteria

0 Days - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria:

  • Neonates outside the age range

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

normal 25-36 gestational week preterm infant

25-36 gestational week preterm infant with IVH

Arm Description

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

Outcomes

Primary Outcome Measures

measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
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.

Secondary Outcome Measures

variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
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.

Full Information

First Posted
February 7, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04270734
Brief Title
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Acronym
PremaTempo
Official Title
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Perception, EEG, Premature Neonates, Discrimination
Keywords
time perception, rhythm, EEG, fNIRS, ERP, premature neonates, discrimination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal 25-36 gestational week preterm infant
Arm Type
Active Comparator
Arm Title
25-36 gestational week preterm infant with IVH
Arm Type
Experimental
Arm Description
25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
Intervention Type
Procedure
Intervention Name(s)
EEG
Intervention Description
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
Intervention Name(s)
NIRS
Intervention Description
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
Primary Outcome Measure Information:
Title
measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
Description
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.
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
Description
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.
Time Frame
at day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: full term neonates between 25 and 36 weeks gestational age Exclusion Criteria: Neonates outside the age range
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Wallois, Pr
Phone
(33)322087775
Email
fabrice.wallois@u-picardie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghilda Ghostine, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy Kongolo, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabrina Goudjil, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
André Léké, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christèle Chazal, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Tourneux, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Coralie Degorre, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilie Bourel, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Routier, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire Héberlé, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Wallois, Pr
Phone
(33)322087775
Email
fabrice.wallois@u-picardie.fr
First Name & Middle Initial & Last Name & Degree
Guy Kongolo, Pr
Phone
(33)322455877
Email
kongolo.guy@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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