Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT07142434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neonatal Umbilical Catheter Pathway Simulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-20', 'size': 274343, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-16T14:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-07-27', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neo Path', 'timeFrame': '12 months', 'description': "Evaluation of the simulator's practicality through a user satisfaction questionnaire."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Simulator Training', 'Neonates and Preterm Infants', 'Catherization']}, 'referencesModule': {'references': [{'pmid': '31758061', 'type': 'RESULT', 'citation': 'Meinen RD, Bauer AS, Devous K, Cowan E. Point-of-care ultrasound use in umbilical line placement: a review. J Perinatol. 2020 Apr;40(4):560-566. doi: 10.1038/s41372-019-0558-8. Epub 2019 Nov 22.'}, {'pmid': '31661695', 'type': 'RESULT', 'citation': 'Kaae R, Kyng KJ, Frederiksen CA, Sloth E, Rosthoj S, Kerrn-Jespersen S, Eika B, Sorensen JL, Henriksen TB. Learning Curves for Training in Ultrasonography-Based Examination of Umbilical Catheter Placement: A Piglet Study. Neonatology. 2020;117(2):144-150. doi: 10.1159/000503176. Epub 2019 Oct 29.'}, {'pmid': '35174113', 'type': 'RESULT', 'citation': "D'Andrea V, Prontera G, Rubortone SA, Pezza L, Pinna G, Barone G, Pittiruti M, Vento G. Umbilical Venous Catheter Update: A Narrative Review Including Ultrasound and Training. Front Pediatr. 2022 Jan 31;9:774705. doi: 10.3389/fped.2021.774705. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': 'Currently, training for umbilical catheter placement in neonates is primarily focused on inserting the catheter into the umbilical vein. However, no models to date allow real-time ultrasound assessment of catheter tip navigation and final positioning during the procedure. This study introduces the first training simulator designed specifically to address this need, enabling operators to practice not only the insertion but also the ultrasonographic localization of the catheter tip during the placement process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experts must have at least 3 years of experience in neonatal abdominal ultrasound or central line placement.\n\nTrainees must be medical residents in their 3rd year or beyond.\n\nExclusion Criteria:\n\n* Less than 3 years of relevant experience for expert participants. Less than 3rd year of specialty training for trainee participants.'}, 'identificationModule': {'nctId': 'NCT07142434', 'acronym': 'NeoPath', 'briefTitle': 'Neonatal Umbilical Catheter Pathway Simulator', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Neonatal Umbilical Catheter Pathway Simulator', 'orgStudyIdInfo': {'id': '7348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'no-experienced neonatal ultrasound practitioners', 'description': 'pratictioners who will test and validate the simulator.', 'interventionNames': ['Device: neonatal Umbilical Catheter Pathway Simulator']}], 'interventions': [{'name': 'neonatal Umbilical Catheter Pathway Simulator', 'type': 'DEVICE', 'description': 'evaluate the quality of simulator', 'armGroupLabels': ['no-experienced neonatal ultrasound practitioners']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Vito D'Andrea", 'role': 'CONTACT', 'email': 'dandrea.vito@gmail.com', 'phone': '+393476334488'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'D ANDREA VITO', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}