Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02112305
Status:
UNKNOWN
Last Update Posted:
2014-11-18
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013224', 'term': 'Status Asthmaticus'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-15', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma severity score', 'timeFrame': '60 minute'}], 'secondaryOutcomes': [{'measure': 'Length of stay in the hospital', 'timeFrame': 'within 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnesium sulphate nebulized'], 'conditions': ['Acute Severe Asthma']}, 'referencesModule': {'references': [{'pmid': '24144222', 'type': 'RESULT', 'citation': 'Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate', 'detailedDescription': 'Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy\n\nExclusion Criteria:\n\n* chronic lung disease\n* history of adverse reaction form magnesium sulphate\n* life threatening condition'}, 'identificationModule': {'nctId': 'NCT02112305', 'briefTitle': 'Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Queen Sirikit National Institute of Child Health'}, 'officialTitle': 'Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma', 'orgStudyIdInfo': {'id': 'EC 104/2557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'isotonic magnesium sulphate', 'description': '2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval', 'interventionNames': ['Drug: isotonic magnesium sulphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50% magnesium sulphate', 'description': 'magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose', 'interventionNames': ['Drug: 50% magnesium sulphate']}], 'interventions': [{'name': 'isotonic magnesium sulphate', 'type': 'DRUG', 'otherNames': ['magnesium sulfate'], 'description': '2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval', 'armGroupLabels': ['isotonic magnesium sulphate']}, {'name': '50% magnesium sulphate', 'type': 'DRUG', 'otherNames': ['magnesium sulfate'], 'description': 'magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose', 'armGroupLabels': ['50% magnesium sulphate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Queen Sirikit National Institute of Child Health', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Tassalapa Daengsuwan, Pediatrician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Queen Sirikit National Institute of Child Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Sirikit National Institute of Child Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Tassalapa Daengsuwan', 'investigatorAffiliation': 'Queen Sirikit National Institute of Child Health'}}}}