Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-04-21 @ 12:09 PM
Study NCT ID:
NCT02590718
Status:
UNKNOWN
Last Update Posted:
2015-10-29
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management Following Lumbar Puncture In Children
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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.', 'timeFrame': 'up to five days postoperation'}], 'secondaryOutcomes': [{'measure': 'Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.', 'timeFrame': 'up to four hours postoperation'}, {'measure': 'comfort degree', 'timeFrame': 'up to four hours postoperation', 'description': 'evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale'}, {'measure': 'whether bad memories exist or not', 'timeFrame': 'up to four hours postoperation', 'description': 'A questionaire about the operation for all parents and children will be investigated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Puncture Complications']}, 'referencesModule': {'references': [{'pmid': '30987603', 'type': 'DERIVED', 'citation': 'Hu B, Chen TM, Liu B, Chi W, Miao YQ, Nie XL, Peng XX, Liu G. Optimal management after paediatric lumbar puncture: a randomized controlled trial. BMC Neurol. 2019 Apr 13;19(1):64. doi: 10.1186/s12883-019-1275-9.'}]}, 'descriptionModule': {'briefSummary': 'The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.', 'detailedDescription': 'The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of comfortable LP will be established upon completion of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with indications of lumbar puncture;\n* voluntarily signed the informed consent\n\nExclusion Criteria:\n\n* topical anesthetic skin allergies;\n* skin infection in lumbar puncture site;\n* severe intracranial hypertension;\n* unstable vital signs;\n* coagulopathy;\n* intracranial hemorrhage and occupying;\n* low back pain;\n* headache and low back pain before lumbar puncture;\n* past headache after lumbar puncture;\n* mental retardation, neuropsychiatric symptoms;\n* children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);\n* the case with repeated puncture in one operation'}, 'identificationModule': {'nctId': 'NCT02590718', 'acronym': 'MFLPIC', 'briefTitle': 'Management Following Lumbar Puncture In Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Management Following Lumbar Puncture In Children', 'orgStudyIdInfo': {'id': '20150826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'optimized postoperative management(lying without the pillow for half an hour after lumbar puncture)', 'interventionNames': ['Procedure: optimized postoperative management']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'traditional postoperative management(lying without the pillow and fasting water and food for four hours after lumbar puncture)'}], 'interventions': [{'name': 'optimized postoperative management', 'type': 'PROCEDURE', 'description': 'lying without the pillow for half an hour after lumbar puncture', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bing Hu, postgraduate', 'role': 'CONTACT', 'email': 'hubing6028@163.com'}, {'name': 'Bing Liu, postgraduate', 'role': 'CONTACT', 'email': '1191009583@163.com'}], 'overallOfficials': [{'name': 'Gang Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Beijing Childrens' Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician/Professor', 'investigatorFullName': 'Gang Liu', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}