| Registry | NCT06137040 |
|---|
| Status | Recruiting |
|---|
| Phase | Early Phase 1 |
|---|
| Study type | Interventional; randomized, parallel, masking: double, treatment |
|---|
| Enrollment | 100 (Estimated) |
|---|
| Sponsor | University of Oklahoma (Other) |
|---|
| Conditions | Asthma in Children, Asthma Attack |
|---|
| Interventions | Magnesium Sulfate within the first hour, No Magnesium sulfate within the first hour (Drug, other) |
|---|
| Dates | start 2023-11-30, primary completion 2025-05-31 (estimated), completion 2025-05-31 (estimated), first posted 2023-11-18, last updated 2024-12-06 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Asthma in Children All trials for Asthma Attack All trials of Magnesium Sulfate within the first hour All trials of No Magnesium sulfate within the first hour
-Summary
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.
Expand all sections · Collapse all
+Detailed description
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.
The 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:
15-19 kg: 750 mg
20-29 kg: 1000 mg
30-39 kg: 1500 mg
>40 kg: 2000 mg
Enrolled 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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Magnesium Sulfate in the first hour | Experimental | Drug: Magnesium Sulfate within the first hour | These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids). |
| No Magnesium Sulfate | Placebo comparator | Other: No Magnesium sulfate within the first hour | These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary. |
- Magnesium Sulfate within the first hour (Drug), also known as Magnesium within the first hour: The experimental group will receive 40-50 mg/kg 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/kg normal saline bolus (max 1000 mL) to avoid possible hypotension.
15-19 kg: 750 mg
20-29 kg: 1000 mg
30-39 kg: 1500 mg
>40 kg: 2000 mg
- No Magnesium sulfate within the first hour (Other), also known as No magnesium within the first hour: The control group will not receive IV magnesium sulfate within the first hour of treatment.
+Outcome measures
Primary outcomes
- Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group [From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week]: 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.
Secondary outcomes
- Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group [Time of initiation of therapy to discharge from the hospital, up to 2 weeks]: 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.
+Eligibility
Sex: All, ages: 5 Years to 17 Years
Inclusion Criteria:
* Ages 5-17 years old
* Presents to the ED with a respiratory score in the "Moderate" range (6
* Parent(s)/Caregiver(s) speak English
Exclusion Criteria:
* 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)/Caregiver(s) do not speak English
+Locations (1)
| Facility | City | Country | Status |
|---|
| Oklahoma Children's Hospital | Oklahoma City, Oklahoma | United States | Recruiting |
+Publications
- 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/adc.2004.050005. PMID 15613519
- 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 25024668
- 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/ppul.23482. Epub 2016 May 24. PMID 27218606
- 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/hpeds.2017-0088. Online ahead of print. PMID 29305409
- 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/aap.2012.eng.291. English, Spanish. PMID 22859321
- 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: 10.1002/14651858.CD001490. PMID 10796650
+Investigators