Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT05772416
Status:
UNKNOWN
Last Update Posted:
2023-03-16
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neonatal Neurological Examination to Detect Infants at Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hammersmith Neonatal and infant Neurological examination', 'timeFrame': '5 years', 'description': 'neurological examination witha score from 0 to 75 with 75 indicating best performance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Encephalopathy']}, 'descriptionModule': {'briefSummary': 'The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.', 'detailedDescription': 'The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.\n\nInfants at risk of neurological abnormlaiyies, such as very pèretrm infants and infants with asphyxia or with overt neyurologocal abnormla signs suh as convilsions will be assessed with a structured neurological examination and followed over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'minimumAge': '6 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions', 'eligibilityCriteria': 'Inclusion Criteria:\n\nall newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions\n\nExclusion Criteria:\n\nfamilies unwilling to sign consent'}, 'identificationModule': {'nctId': 'NCT05772416', 'briefTitle': 'Neonatal Neurological Examination to Detect Infants at Risk', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities', 'orgStudyIdInfo': {'id': '4313'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Eugenio Mercuri', 'role': 'CONTACT', 'email': 'eugeniomaria.mercuri@policlinicogemelli.it', 'phone': '063015', 'phoneExt': '5340'}], 'facility': 'Policlinico gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Eugenio Mercuri, MD', 'role': 'CONTACT', 'email': 'eugeniomaria.mercuri@policlinicogemelli.it', 'phone': '+39 063015', 'phoneExt': '5340'}, {'name': 'Marika Pane, MD', 'role': 'CONTACT', 'email': 'marika.pane@policlinicogemelli.it', 'phone': '063015', 'phoneExt': '5340'}], 'overallOfficials': [{'name': 'Eugenio Mercuri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'F Policlinico Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only aggregate data as from consensus'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}