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

Not Applicable

Recruiting

• Conditions: Discrimination; Premature Neonates; EEG; Time Perception
• Interventions: Procedure: EEG; Procedure: NIRS

• Registration Number: NCT04270734
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria

• Neonates outside the age range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal 25-36 gestational week preterm infant	EEG	-
25-36 gestational week preterm infant with IVH	NIRS	25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
25-36 gestational week preterm infant with IVH	EEG	25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
normal 25-36 gestational week preterm infant	NIRS	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France