Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 7:16 AM
Study NCT ID:
NCT02344368
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2015-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '1 week', 'description': 'assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sucrose', 'Anesthesia', 'Blood specimen collection', 'Injections, Intravenous'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '30188590', 'type': 'RESULT', 'citation': 'Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* born preterm\n* more than 1000 gram\n\nExclusion Criteria:\n\n* severe intraventricular hemorrhage\n* cerebral malformations\n* other malformations requiring surgery\n* medication that may impair pain expression (opioids, paracetamol, sedatives)'}, 'identificationModule': {'nctId': 'NCT02344368', 'briefTitle': 'The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses', 'orgStudyIdInfo': {'id': '2014/2089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.2 ml sucrose', 'description': 'on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling', 'interventionNames': ['Other: 0.2 ml sucrose 25%', 'Other: 0.5 ml sucrose 25%']}, {'type': 'EXPERIMENTAL', 'label': '0.5 ml sucrose', 'description': 'on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling', 'interventionNames': ['Other: 0.2 ml sucrose 25%', 'Other: 0.5 ml sucrose 25%']}], 'interventions': [{'name': '0.2 ml sucrose 25%', 'type': 'OTHER', 'description': 'Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling', 'armGroupLabels': ['0.2 ml sucrose', '0.5 ml sucrose']}, {'name': '0.5 ml sucrose 25%', 'type': 'OTHER', 'description': 'Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling', 'armGroupLabels': ['0.2 ml sucrose', '0.5 ml sucrose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Empangeni', 'country': 'South Africa', 'facility': 'Lower Umfolozi Rigional War Memorial Hospital, NICU', 'geoPoint': {'lat': -28.76197, 'lon': 31.89329}}], 'overallOfficials': [{'name': 'Håkon Bergseng, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Lower Umfolozi Regional War Memorial Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}