Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-22 @ 7:21 PM
Study NCT ID:
NCT02174705
Status:
UNKNOWN
Last Update Posted:
2014-08-15
First Post:
2014-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rotavirus vs. Sucrose for Vaccine Injection Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013395', 'term': 'Sucrose'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2014-06-22', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety', 'timeFrame': 'immediately after vaccinations in 5 minutes', 'description': 'Number of infants spitting up/gagging with administration of study liquid'}, {'measure': 'Satisfaction', 'timeFrame': 'immediately after vaccination in 1 minute', 'description': 'Parent rated satisfaction with pain control using likert scale'}], 'primaryOutcomes': [{'measure': 'Distress', 'timeFrame': 'immediately after vaccinations in 15 seconds', 'description': 'Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall'}], 'secondaryOutcomes': [{'measure': 'Distress', 'timeFrame': 'immediately after vaccinations in 1 minute intervals for 2 minutes', 'description': 'Observer rated cry duration after vaccination'}, {'measure': 'Distress', 'timeFrame': 'immediately after vaccinations in 1 minute', 'description': 'Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)'}, {'measure': 'Distress', 'timeFrame': 'immediately after vaccinations in 1 minute', 'description': 'Parent rated distress after each injection using a Numerical Rating Scale (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaccination', 'pain management', 'sucrose', 'rotavirus'], 'conditions': ['Vaccination Pain Management']}, 'descriptionModule': {'briefSummary': 'This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life\n\nExclusion Criteria:\n\n* impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial'}, 'identificationModule': {'nctId': 'NCT02174705', 'briefTitle': 'Rotavirus vs. Sucrose for Vaccine Injection Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants', 'orgStudyIdInfo': {'id': '30427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sucrose', 'description': 'Sucrose prior to vaccine injections', 'interventionNames': ['Drug: Sucrose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rotavirus', 'description': 'Rotavirus prior to vaccine injections', 'interventionNames': ['Drug: Rotavirus']}], 'interventions': [{'name': 'Sucrose', 'type': 'DRUG', 'description': 'Sucrose 24% orally prior to vaccine injections', 'armGroupLabels': ['Sucrose']}, {'name': 'Rotavirus', 'type': 'DRUG', 'description': 'Rotavirus vaccine orally prior to vaccine injections', 'armGroupLabels': ['Rotavirus']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5N 1A8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dan Flanders, MD', 'role': 'CONTACT', 'phone': '(416) 848-7665'}, {'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-8822'}, {'name': 'Dan Flanders, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kindercare', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 3M2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-8822'}, {'name': 'Dan Flanders, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anna Taddio', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-8822'}, {'name': 'Moshe Ipp, MD', 'role': 'CONTACT', 'email': 'mm.ipp@utoronto.ca', 'phone': '416-924-7171'}], 'overallOfficials': [{'name': 'Anna Taddio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Taddio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Taddio', 'investigatorAffiliation': 'University of Toronto'}}}}