An Early Phase 1 interventional study of Magnesium Sulfate within the first hour and No Magnesium sulfate within the first hour in Asthma in Children and Asthma Attack, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Oklahoma · Early Phase 1, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 100 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
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).
Drug: 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.
Other: No Magnesium sulfate 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
Also known as: Magnesium within the first hour
The control group will not receive IV magnesium sulfate within the first hour of treatment.
Also known as: No magnesium within the first hour
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.
Time frame: From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week
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 frame: Time of initiation of therapy to discharge from the hospital, up to 2 weeks
Plan to share: No
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