[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06137040":3,"trial-entities:NCT06137040":122,"trial-summary:NCT06137040":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":53,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":72,"locations":74,"central_contacts":90,"overall_officials":98,"references":101,"see_also_links":121},"NCT06137040","16339","Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation","RECRUITING","2025-05-31","2024-12","2024-12-06","2023-11-30","University of Oklahoma","OTHER",true,"This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.","Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.\n\nThe study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:\n\n15-19 kg: 750 mg\n\n20-29 kg: 1000 mg\n\n30-39 kg: 1500 mg\n\n\\>40 kg: 2000 mg\n\nEnrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.",[18,19],"Asthma in Children","Asthma Attack",[21,22,23,24],"asthma exacerbation","magnesium sulfate","asthma","asthma attack","INTERVENTIONAL","TREATMENT",[28],"EARLY_PHASE1",{"count":30,"type":31},100,"ESTIMATED",[33,41],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Magnesium Sulfate within the first hour","The experimental group will receive 40-50 mg\u002Fkg of IV magnesium sulfate will be given to the experimental group alongside the first line asthma therapies (ie inhaled beta agonists, IV steroids). This will be given with a 20 mL\u002Fkg normal saline bolus (max 1000 mL) to avoid possible hypotension.\n\n15-19 kg: 750 mg\n\n20-29 kg: 1000 mg\n\n30-39 kg: 1500 mg\n\n\\>40 kg: 2000 mg",[38],"Magnesium Sulfate in the first hour",[40],"Magnesium within the first hour",{"type":13,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"No Magnesium sulfate within the first hour","The control group will not receive IV magnesium sulfate within the first hour of treatment.",[45],"No Magnesium Sulfate",[47],"No magnesium within the first hour",[49],{"measure":50,"description":51,"timeFrame":52},"Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group","Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can reduce length of stay in the ED, general hospital bed or PICU. The data will also be analyzed to determine if more patients in the experimental group were able to be discharged from the emergency department compared to the control group.","From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week",[54],{"measure":55,"description":56,"timeFrame":57},"Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group","Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can decrease the need for respiratory support including invasive and non-invasive respiratory support devices.","Time of initiation of therapy to discharge from the hospital, up to 2 weeks","ALL","5 Years","17 Years",false,{"inclusion":63,"exclusion":67,"raw_text":71},[64,65,66],"Ages 5-17 years old","Presents to the ED with a respiratory score in the \"Moderate\" range (6","Parent(s)\u002FCaregiver(s) speak English",[68,69,70],"Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients","Patients who are pregnant","Parent(s)\u002FCaregiver(s) do not speak English","Inclusion Criteria:\n\n* Ages 5-17 years old\n* Presents to the ED with a respiratory score in the \"Moderate\" range (6\n* Parent(s)\u002FCaregiver(s) speak English\n\nExclusion Criteria:\n\n* Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients\n* Patients who are pregnant\n* Parent(s)\u002FCaregiver(s) do not speak English",[73],"CHILD",[75],{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"Oklahoma Children's Hospital","Oklahoma City","Oklahoma","73104","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Ryan McKee, MD","CONTACT","405-271-2429","Ryan-McKee@ouhsc.edu",{"lat":88,"lon":89},35.46756,-97.51643,[91,94],{"name":83,"role":84,"phone":92,"email":93},"4056308997","ryan-mckee@ouhsc.edu",{"name":95,"role":84,"phone":96,"email":97},"Jaclyn Urquiola Sorzano, DO","7863906297","jaclyn-urquiola@ouhsc.edu",[99],{"name":83,"affiliation":12,"role":100},"PRINCIPAL_INVESTIGATOR",[102,106,109,112,115,118],{"pmid":103,"type":104,"citation":105},"15613519","BACKGROUND","Cheuk DK, Chau TC, Lee SL. A meta-analysis on intravenous magnesium sulphate for treating acute asthma. Arch Dis Child. 2005 Jan;90(1):74-7. doi: 10.1136\u002Fadc.2004.050005.",{"pmid":107,"type":104,"citation":108},"25024668","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\u002F1551-6776-19.2.91.",{"pmid":110,"type":104,"citation":111},"27218606","Liu X, Yu T, Rower JE, Campbell SC, Sherwin CM, Johnson MD. Optimizing the use of intravenous magnesium sulfate for acute asthma treatment in children. Pediatr Pulmonol. 2016 Dec;51(12):1414-1421. doi: 10.1002\u002Fppul.23482. Epub 2016 May 24.",{"pmid":113,"type":104,"citation":114},"29305409","Shein SL, Farhan O, Morris N, Mahmood N, Alter SJ, Biagini Myers JM, Gunkelman SM, Kercsmar CM, Khurana Hershey GK, Martin LJ, McCoy KS, Ruddy JR, Ross KR. Adjunctive Pharmacotherapies in Children With Asthma Exacerbations Requiring Continuous Albuterol Therapy: Findings From The Ohio Pediatric Asthma Repository. Hosp Pediatr. 2018 Jan 5;8(2):89-95. doi: 10.1542\u002Fhpeds.2017-0088. Online ahead of print.",{"pmid":116,"type":104,"citation":117},"22859321","Torres S, Sticco N, Bosch JJ, Iolster T, Siaba A, Rocca Rivarola M, Schnitzler E. Effectiveness of magnesium sulfate as initial treatment of acute severe asthma in children, conducted in a tertiary-level university hospital: a randomized, controlled trial. Arch Argent Pediatr. 2012 Aug;110(4):291-6. doi: 10.5546\u002Faap.2012.eng.291. English, Spanish.",{"pmid":119,"type":104,"citation":120},"10796650","Rowe BH, Bretzlaff JA, Bourdon C, Bota GW, Camargo CA Jr. Magnesium sulfate for treating exacerbations of acute asthma in the emergency department. Cochrane Database Syst Rev. 2000;2000(2):CD001490. doi: 10.1002\u002F14651858.CD001490.",[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Asthma",[],{"nct_id":4,"found":14,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study planning to enroll 100 participants. Participants will be randomly assigned to receive either IV magnesium sulfate or standard care, and the medical team will know which treatment each child receives.","completed","Early Magnesium Sulfate for Moderate Asthma Attacks in Children","This study is looking at whether giving intravenous (IV) magnesium sulfate early to children aged 5-17 who come to the emergency department with a moderate asthma attack can help them get better faster. The study aims to see if early magnesium sulfate can reduce how long children stay in the emergency department or hospital, decrease the need for intensive care, or lessen the need for breathing support. Some children will receive IV magnesium sulfate within the first hour of treatment along with standard asthma care, while others will receive standard care without early magnesium sulfate. The main goal is to compare the length of hospital stay between these two groups.","Your length of stay will be measured from the start of treatment until discharge from the emergency department or admitting unit, up to one week.",110,"If you participate, you would receive either IV magnesium sulfate or standard care for your asthma attack. Your clinical progress, including length of stay and need for respiratory support, will be reviewed.","Not stated in the trial record.",[35],"v2"]