Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03553134
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2018-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right and left average velocity of the cerebral artery', 'timeFrame': 'Change from birth to 48 hours of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Newborn']}, 'descriptionModule': {'briefSummary': 'There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.\n\nBlood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.\n\nThe objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns over 35 weeks of amenorrhoea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written consent of parent\n* Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward\n\nExclusion Criteria:\n\n* person not affiliated to a health insurance scheme\n* Sepsis\n* Ductal dependent heart disease\n* Neurological impairment (anoxoischemic encephalopathy Sarnat\\>1, pH\\<7 and/or lactates\\>11, meningitis)\n* Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)\n* Potentially lethal malformation\n* Anemia (hemoglobin\\<14g/dl)\n* Polyglobulia (hemoglobin\\>22g/dl)\n* Small for gestational age (weight\\<10th percentile)\n* Large for gestational age (weight\\>97th percentile)\n* Proven gestational diabetes (non-insulin-dependent and insulin-dependent)\n* Maternal medical treatment (cardiac or anti-epileptic)\n* Inadequate parent understanding'}, 'identificationModule': {'nctId': 'NCT03553134', 'acronym': 'VELOCITE', 'briefTitle': 'Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward', 'orgStudyIdInfo': {'id': 'LITZLER-RENAULT 2018 VELOCITE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transcranial doppler ultrasound scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)'}, {'name': 'ultrasound scan centered on the arterial canal', 'type': 'DIAGNOSTIC_TEST', 'description': 'Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}