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

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

EEG
Time Perception
Discrimination
Premature Neonates

Treatments

Procedure: EEG
Procedure: NIRS

Study type

Interventional

Funder types

Other

Identifiers

NCT04270734
PI2019_843_0041

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

Under 1 day old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • full term neonates between 25 and 36 weeks gestational age

Exclusion criteria

  • Neonates outside the age range

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

normal 25-36 gestational week preterm infant
Active Comparator group
Treatment:
Procedure: NIRS
Procedure: EEG
25-36 gestational week preterm infant with IVH
Experimental group
Description:
25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
Treatment:
Procedure: NIRS
Procedure: EEG

Trial contacts and locations

1

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Central trial contact

Fabrice Wallois, Pr

Data sourced from clinicaltrials.gov

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