Clinical trial NCT04270734: Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Official title: Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time Perception
EEG
Premature Neonates
Discrimination
Keywords: time perception
rhythm
EEG
fNIRS
ERP
premature neonates
discrimination
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 240
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria:

* Neonates outside the age range

Primary outcomes:
measure: measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
timeFrame: at day 0
Secondary outcomes:
measure: variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
timeFrame: at day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Ghilda Ghostine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Guy Kongolo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Sabrina Goudjil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: André Léké, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Christèle Chazal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Pierre Tourneux, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Coralie Degorre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Emilie Bourel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Laura Routier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Claire Héberlé, MD
role: PRINCIPAL_INVESTIGATOR
References: