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

EEG Clinical Trial

— PremaTempo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270734
• Other study ID #: PI2019_843_0041
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 2027

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Wallois, Pr
• Phone: (33)322087775
• Email: fabrice.wallois[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 1 Day

Eligibility

Inclusion Criteria:

• full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria:

• Neonates outside the age range

Related Conditions & MeSH terms

• Discrimination
• EEG
• Premature Birth
• Premature Neonates
• Time Perception

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at day 0
Secondary	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.	at day 0