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Recruiting NCT04270734

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

No phase Interventional Time Perception EEG Premature Neonates Discrimination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EEG, NIRS.
Who it may be relevant to
Registry conditions: Time Perception, EEG, Premature Neonates, Discrimination. Basic parameters: 0 Days — 1 Day · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox [Time frame: at day 0]
Secondary outcome measures (1)
  • variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools [Time frame: at day 0]

Eligibility criteria

Inclusion criteria

  • full term neonates between 25 and 36 weeks gestational age

Exclusion criteria

  • Neonates outside the age range

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT04270734 · PI2019_843_0041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗