Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT03277092
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near Infrared Light in Paediatric Blood Drawing Centre
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to perform the procedure', 'timeFrame': 'Intraprocedural', 'description': 'In seconds, from the placement of the tourniquet until the blood flows in the needle'}], 'secondaryOutcomes': [{'measure': 'Success at first attempt', 'timeFrame': 'Intraprocedural', 'description': 'Percentage of success at first attempt'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child, blood drawing procedure, near Infrared light'], 'conditions': ['Blood Drawing Procedure']}, 'referencesModule': {'references': [{'pmid': '29801519', 'type': 'DERIVED', 'citation': 'Conversano E, Cozzi G, Pavan M, Minute M, Gortan E, Montico M, Vecchi Brumatti L, Ronfani L, Barbi E. Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure. Ital J Pediatr. 2018 May 25;44(1):60. doi: 10.1186/s13052-018-0501-1.'}]}, 'descriptionModule': {'briefSummary': 'Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.\n\nThe aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects accessing the outpatient blood-drawing service\n\nExclusion Criteria:\n\n* application of topical anaesthetic cream'}, 'identificationModule': {'nctId': 'NCT03277092', 'briefTitle': 'Near Infrared Light in Paediatric Blood Drawing Centre', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure', 'orgStudyIdInfo': {'id': 'RC 22/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VeinViewer® group', 'description': 'Use of near infrared light to perform blood draw (VeinViewer®)', 'interventionNames': ['Device: VeinViewer®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care group', 'description': 'Blood drawing performed traditionally', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'VeinViewer®', 'type': 'DEVICE', 'description': 'Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site', 'armGroupLabels': ['VeinViewer® group']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'The blood drawing is performed traditionally', 'armGroupLabels': ['Usual care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34137', 'city': 'Trieste', 'country': 'Italy', 'facility': 'IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Egidio Barbi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Burlo Garofolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}