Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-24 @ 4:54 AM
Study NCT ID:
NCT04086056
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2019-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CraNIRS Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003398', 'term': 'Craniosynostoses'}], 'ancestors': [{'id': 'D013580', 'term': 'Synostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional cerebral oxygen saturation measure', 'timeFrame': 'Day 0 before anesthesia', 'description': 'Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors'}, {'measure': 'Regional cerebral oxygen saturation measure', 'timeFrame': 'Day 0 during surgery', 'description': 'Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors'}, {'measure': 'Regional cerebral oxygen saturation measure', 'timeFrame': 'Day 0 after extubation', 'description': 'Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Craniosynostoses']}, 'descriptionModule': {'briefSummary': 'Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.\n\nIn some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.\n\nIn this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.\n\nDetermining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with craniosynostosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys and girls.\n* Aged 3 to 18 months old.\n* Subjects with a craniosynostosis diagnosis confirmed by imaging.\n* Craniosynostosis requiring a corrective surgery in ventral position.\n* Parents/ legal guardian must provide non opposition prior to participation in the study.\n\nExclusion Criteria:\n\n\\- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.'}, 'identificationModule': {'nctId': 'NCT04086056', 'acronym': 'CraNIRS', 'briefTitle': 'CraNIRS Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis', 'orgStudyIdInfo': {'id': '69HCL19_0568'}, 'secondaryIdInfos': [{'id': '2019-A02390-57', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with craniosynostosis', 'description': 'Children with craniosynostosis who will be operated in prone position.', 'interventionNames': ['Other: NIRS monitoring']}], 'interventions': [{'name': 'NIRS monitoring', 'type': 'OTHER', 'description': 'Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.', 'armGroupLabels': ['Children with craniosynostosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon service neurochirurgie pédiatrique', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Federico DI ROCCO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon service neurochirurgie pédiatrique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}