Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 1:39 PM
Study NCT ID:
NCT04270734
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2020-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox', 'timeFrame': 'at day 0', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools', 'timeFrame': 'at day 0', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['time perception', 'rhythm', 'EEG', 'fNIRS', 'ERP', 'premature neonates', 'discrimination'], 'conditions': ['Time Perception', 'EEG', 'Premature Neonates', 'Discrimination']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full term neonates between 25 and 36 weeks gestational age\n\nExclusion Criteria:\n\n* Neonates outside the age range'}, 'identificationModule': {'nctId': 'NCT04270734', 'acronym': 'PremaTempo', 'briefTitle': 'Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood', 'orgStudyIdInfo': {'id': 'PI2019_843_0041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal 25-36 gestational week preterm infant', 'interventionNames': ['Procedure: EEG', 'Procedure: NIRS']}, {'type': 'EXPERIMENTAL', 'label': '25-36 gestational week preterm infant with IVH', 'description': '25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH)', 'interventionNames': ['Procedure: EEG', 'Procedure: NIRS']}], 'interventions': [{'name': 'EEG', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['25-36 gestational week preterm infant with IVH', 'normal 25-36 gestational week preterm infant']}, {'name': 'NIRS', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['25-36 gestational week preterm infant with IVH', 'normal 25-36 gestational week preterm infant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice Wallois, Pr', 'role': 'CONTACT', 'email': 'fabrice.wallois@u-picardie.fr', 'phone': '(33)322087775'}, {'name': 'Guy Kongolo, Pr', 'role': 'CONTACT', 'email': 'kongolo.guy@chu-amiens.fr', 'phone': '(33)322455877'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Fabrice Wallois, Pr', 'role': 'CONTACT', 'email': 'fabrice.wallois@u-picardie.fr', 'phone': '(33)322087775'}], 'overallOfficials': [{'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', 'affiliation': 'CHU Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}