Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01612494
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2012-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypertonic Saline as Therapy for Pediatric Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lumba_a@kids.wustl.edu', 'phone': '314-362-4325', 'title': 'Dr. Angela Lumba-Brown', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No serious adverse events were reported, collected, or observed during this study. Total number of participants were 44. Other adverse events were not recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Saline', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hypertonic Saline', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline'}, {'id': 'OG001', 'title': 'Hypertonic Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following therapy to 2-3 days post discharge', 'description': 'Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Saline'}, {'id': 'FG001', 'title': 'Hypertonic Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited over the course of one year from a single center's pediatric emergency department", 'preAssignmentDetails': 'No enrolled patients were excluded from the trial'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Saline'}, {'id': 'BG001', 'title': 'Hypertonic Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '3', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '12', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2012-05-29', 'resultsFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2012-06-03', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-20', 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Following therapy to 2-3 days post discharge', 'description': 'Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury.\n\nThe study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline.\n\nThe null hypothesis was that there would be no difference in change of reported pain in either group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-17 years old\n* consent obtained\n* pain as a symptom of concussion\n* head CT negative for intracranial pathology\n\nExclusion Criteria:\n\n* younger than 4 years or older than 17 years\n* multi trauma\n* cardiac, neuro, renal history of disease\n* seizure\n* narcotic, drug use\n* pregnancy\n* head CT with traumatic intracranial pathology\n* no consent'}, 'identificationModule': {'nctId': 'NCT01612494', 'briefTitle': 'Hypertonic Saline as Therapy for Pediatric Concussion', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department', 'orgStudyIdInfo': {'id': 'HTS-100423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'interventionNames': ['Other: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertonic Saline', 'interventionNames': ['Drug: Hypertonic Saline']}], 'interventions': [{'name': 'Hypertonic Saline', 'type': 'DRUG', 'otherNames': ['3%', 'HTS'], 'description': 'intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour', 'armGroupLabels': ['Hypertonic Saline']}, {'name': 'Normal Saline', 'type': 'OTHER', 'otherNames': ['NS'], 'description': 'intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital Emergency Department", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Angela K Lumba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'Mary Hilfiker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Angela Lumba, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}