Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
PremaTempo
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
June 10, 2025
June 1, 2025
7 years
February 7, 2020
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
at day 0
Study Arms (2)
normal 25-36 gestational week preterm infant
ACTIVE COMPARATOR25-36 gestational week preterm infant with IVH
EXPERIMENTAL25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)
Interventions
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
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
Eligibility Criteria
You may qualify if:
- full term neonates between 25 and 36 weeks gestational age
You may not qualify if:
- Neonates outside the age range
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
Study Officials
- PRINCIPAL INVESTIGATOR
Ghilda Ghostine, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Guy Kongolo, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Sabrina Goudjil, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
André Léké, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Christèle Chazal, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Pierre Tourneux, Pr
CHU Amiens
- PRINCIPAL INVESTIGATOR
Coralie Degorre, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Emilie Bourel, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Laura Routier, MD
CHU Amiens
- PRINCIPAL INVESTIGATOR
Claire Héberlé, MD
CHU Amiens
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 17, 2020
Study Start
February 1, 2020
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share