Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-28 @ 9:12 AM
Study NCT ID:
NCT04497766
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2020-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.', 'timeFrame': '6 hours', 'description': 'The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.'}], 'secondaryOutcomes': [{'measure': 'duration of ICU stay', 'timeFrame': '72 hours/3 days', 'description': 'this will be measured in hours'}, {'measure': 'duration of hospital stay', 'timeFrame': '120 hours/5 days', 'description': 'this will be measured in hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma in children', 'intravenous magnesium sulphate', 'nebulized magnesium sulphate'], 'conditions': ['Asthma in Children']}, 'referencesModule': {'references': [{'pmid': '24429155', 'type': 'BACKGROUND', 'citation': 'Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22.'}, {'pmid': '25024668', 'type': 'BACKGROUND', 'citation': 'Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.'}, {'pmid': '24429154', 'type': 'BACKGROUND', 'citation': 'Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.'}, {'pmid': '25164315', 'type': 'BACKGROUND', 'citation': 'Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.'}, {'pmid': '23290189', 'type': 'BACKGROUND', 'citation': 'Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.'}, {'pmid': '25652104', 'type': 'BACKGROUND', 'citation': 'Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.'}, {'pmid': '24345031', 'type': 'BACKGROUND', 'citation': 'Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.'}, {'pmid': '27996280', 'type': 'BACKGROUND', 'citation': 'Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/24429155/', 'label': 'Powell C, Dona RK, Lowe, J, Boland A, Petrou S, Doull I, et al. Magnesium sulphate in acute sever asthma in children (MAGNETIC): a randomized, placebo-controlled trial. The Lancet Respiratory Medicine. 2013;1(4):301-8.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25024668', 'label': 'Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients.J Pediatr Pharmacol Ther. 2014;19(2) :91-7.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/24429154/', 'label': 'Goodacre S, Cohen J, Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial.Lancet Respir Med. 2013;1(4'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/25164315/', 'label': 'Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Peadiatrica. 2014;103(12):1301-6'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/23290189/', 'label': 'Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J,et al. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respiratory medicine. 2013;107(3):321-30.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/25652104/', 'label': 'Alansari K, Ahmed W, Davidson B, Alamri M, Zakaria I, Alrifaari M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized tria.Pediatr Pumonol 2015;50(12):1191-9.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/24345031/', 'label': 'Albuali WH. The Use of Intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal.2014;27(17):1809-15.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/27996280/', 'label': 'aengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac/allergy immunol. 2016; 35(2):108-'}]}, 'descriptionModule': {'briefSummary': 'The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.', 'detailedDescription': 'After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes\n\nExclusion Criteria:\n\n* those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness'}, 'identificationModule': {'nctId': 'NCT04497766', 'briefTitle': 'Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma', 'orgStudyIdInfo': {'id': '137/RC/KEMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized magnesium sulphate', 'description': '100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer', 'interventionNames': ['Drug: Nebulized Magnesium sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous magnesium sulphate', 'description': 'Magnesium sulphate according to weight will be given intravenously.', 'interventionNames': ['Drug: Intravenous magnesium sulphate']}], 'interventions': [{'name': 'Nebulized Magnesium sulfate', 'type': 'DRUG', 'otherNames': ['Nebulized MgSO4'], 'description': 'MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes', 'armGroupLabels': ['Nebulized magnesium sulphate']}, {'name': 'Intravenous magnesium sulphate', 'type': 'DRUG', 'otherNames': ['IV MgSO4'], 'description': 'pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour', 'armGroupLabels': ['Intravenous magnesium sulphate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'King edward medical university/mayo hospital lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad-Haroon Hamid, MBBS,FCPS,FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared after publication on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saima Khatoon', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Edward Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Resident in Pediatrics (MD Paeds)', 'investigatorFullName': 'Saima Khatoon', 'investigatorAffiliation': 'King Edward Medical University'}}}}