Early Magnesium Sulfate for Childhood Asthma

Recruiting in Palo Alto (17 mi)

Overseen by Ryan McKee, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Oklahoma

Disqualifiers: Chronic pulmonary disease, Cerebral palsy, others

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Magnesium Sulfate for treating childhood asthma?

Research suggests that Magnesium Sulfate can help children with asthma who do not respond well to initial treatments, as it may improve lung function and reduce the need for hospital admission. ^{1 2 3 4 5}

Is magnesium sulfate safe for children with asthma?

Research suggests that magnesium sulfate is generally safe for children with asthma when used in medical settings, such as hospitals, to help with severe asthma attacks. It is often given as an intravenous (IV) infusion or nebulized (inhaled as a mist) and is considered a second-tier treatment when other medications are not enough. ^{3 4 5 6 7}

How is the drug magnesium sulfate unique in treating childhood asthma?

Magnesium sulfate is unique because it is used as a second-tier treatment for children with severe asthma who do not respond well to initial therapies, like beta(2)-agonists. It can be administered early in high doses or as a prolonged infusion to improve lung function and reduce hospital admissions. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for children aged 5-17 who come to the emergency department with a moderate level of breathing difficulty due to asthma. Their parents or caregivers must speak English. It's not suitable for those outside this age range or with different levels of respiratory distress.

Inclusion Criteria

I am between 5 and 17 years old.

I have moderate breathing difficulties.

My caregiver or I can communicate in English.

Exclusion Criteria

Patients who are pregnant

My parent(s)/caregiver(s) do not speak English.

I have a chronic condition like heart disease or myasthenia gravis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either early administration of IV magnesium sulfate or standard care based on randomization

1 week

In-person visits during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Magnesium Sulfate (Electrolyte Supplement)

Trial Overview The study is testing if giving magnesium sulfate within the first hour of arriving at the hospital helps kids with moderate asthma attacks by reducing their stay in the ER, avoiding admission, and lessening the need for intensive care or breathing support.

Participant Groups

Group I: Magnesium Sulfate in the first hour Experimental Treatment 1 Intervention

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).

Group II: No Magnesium Sulfate Placebo Group 1 Intervention

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 is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

🇪🇺 Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

🇨🇦 Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

🇦🇺 Approved in Australia as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oklahoma Children's Hospital Oklahoma City, OK

Who Is Running the Clinical Trial?

University of Oklahoma Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. [2006] Magnesium sulfate has been shown to benefit asthmatic children and adults with poor responses to initial beta(2)-agonist therapy in the emergency department. We sought to determine whether the routine early administration of high-dose magnesium would benefit moderate to severely ill children with acute asthma.

2. England pubmed.ncbi.nlm.nih.gov

Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. [2014] Little evidence is available for the effect of nebulised magnesium sulphate (MgSO(4)) in acute asthma in children. We assessed the effect of MgSO(4) treatment in children with severe acute asthma.

3. England pubmed.ncbi.nlm.nih.gov

Nebulized Salbutamol with or without Magnesium Sulphate in the Management of Acute Asthma in Children in India: A Randomized Controlled Trial. [2022] There is inconclusive evidence on the role of nebulized magnesium sulphate (MgSO4) in the management of acute asthma in paediatric population.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Magnesium Sulfate Infusions for Status Asthmaticus in Children: A Systematic Review. [2022] Magnesium sulfate is a second-tier therapy for asthma exacerbations in children; guidelines recommend a single-dose to improve pulmonary function and decrease the odds of admission to the in-patient setting. However, many clinicians utilize prolonged magnesium sulfate infusions for children with refractory asthma. The purpose of this review is to describe the efficacy and safety of magnesium sulfate infusions administered over ≥ 1 h in children with status asthmaticus.

5. England pubmed.ncbi.nlm.nih.gov

MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. [2022] There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of acute asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn.

6. Australia pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? [2022] To review current evidence regarding the safety of intravenous bolus magnesium sulphate for the treatment of children with acute severe asthma in the non-critical care setting.

7. Brazil pubmed.ncbi.nlm.nih.gov

[Use of the intravenous and nebulized magnesium sulfate for the treatment of the acute asthma in the emergence]. [2014] Magnesium sulfate has been shown to benefit asthmatic children and adults with poor responses to initial beta-agonist therapy and systemic corticoids in the emergency department. The aim of this study was to realize a no systematic review about the treatment of the acute asthma with intravenous and nebulized magnesium sulfate in the emergence.