Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06626620
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2024-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-treatment PEFR', 'timeFrame': '4 hours', 'description': 'Post-treatment, children response to treatment was measured by noting PEFR'}], 'secondaryOutcomes': [{'measure': 'Oxygen Saturation', 'timeFrame': '4 hours', 'description': 'Post-treatment, oxygen saturation was measured using Spirometry'}, {'measure': 'Heart Rate', 'timeFrame': '4-hours', 'description': 'Post-treatment, heart rate was measured'}, {'measure': 'Respiratory rate', 'timeFrame': '4 hours', 'description': 'Post-treatment, heart rate was measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'intravenous', 'magnesium sulfate', 'terbutaline'], 'conditions': ['Acute Exacerbation of Asthma']}, 'descriptionModule': {'briefSummary': 'This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.', 'detailedDescription': 'Despite the established roles of both magnesium sulfate and terbutaline in the management of severe asthma exacerbations, there is limited comparative data on their efficacy and safety in the pediatric population. Understanding the relative benefits and risks of these therapies is crucial for optimizing treatment strategies and improving patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known cases of asthma\n* Minimum duration of asthma as 6 months\n* Presenting with acute exacerbation of asthma\n* Requiring emergency treatment.\n\nExclusion Criteria:\n\n* Children having chronic respiratory diseases (cystic fibrosis, bronchopuonary dysplasia)\n* Children with cardiac diseases\n* Children who were hospitalized in the past 2-weeks due to any reasons\n* Children using oral or intravenous corticosteroids or other systemic medications\n* Children who were unable to undergo PEFR measurements due to any reasons'}, 'identificationModule': {'nctId': 'NCT06626620', 'briefTitle': 'Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma', 'orgStudyIdInfo': {'id': 'NISHTARASTHMASTUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Magnesium Sulfate', 'description': 'Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells.', 'interventionNames': ['Drug: Magnesium Sulphate infusion']}, {'type': 'EXPERIMENTAL', 'label': 'IV Terbutaline', 'description': 'Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective.', 'interventionNames': ['Drug: Terbutaline Infusion']}], 'interventions': [{'name': 'Magnesium Sulphate infusion', 'type': 'DRUG', 'otherNames': ['IV MgSO4'], 'description': 'Received IV magnesium sulfate (50 mg/kg up to a maximum dose of 2 g) administered over 20 minutes', 'armGroupLabels': ['IV Magnesium Sulfate']}, {'name': 'Terbutaline Infusion', 'type': 'DRUG', 'description': 'Received IV terbutaline (10 mcg/kg bolus followed by a continuous infusion of 0.4 mcg/kg/min) for up to 4 hours', 'armGroupLabels': ['IV Terbutaline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Nishtar Hospital', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Arif Zulqarnain, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Pediatrics, Nishtar Hospital, Multan, Pakistan'}, {'name': 'Muhammad Salman, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Nishtar Hospital, Multan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nishtar Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}