Early Magnesium Sulfate for Childhood Asthma

Overseen By Jaclyn Urquiola Sorzano, DO

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Disqualifiers: Chronic pulmonary disease, Cerebral palsy, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early administration of magnesium sulfate can more effectively manage moderate asthma attacks in children. The goal is to determine if this treatment can prevent hospital admissions, reduce emergency room time, and decrease the need for additional breathing support. Participants will receive magnesium sulfate within the first hour of treatment or not, to compare outcomes. Children with at least a two-year history of asthma and moderate asthma episodes may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how magnesium sulfate works in children with asthma, offering participants a chance to be among the first to receive this treatment.

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.

Is there any evidence suggesting that magnesium sulfate is likely to be safe for children with asthma?

Research has shown that administering magnesium sulfate through an IV is safe for children experiencing asthma attacks. Studies have found that doses between 50 to 75 mg per kg are well-tolerated by children with moderate to severe asthma symptoms in emergency situations, with no major safety issues reported. Additionally, using magnesium sulfate for an extended period at a maximum dose of 30 mg per kg per hour is considered safe and may aid during asthma flare-ups. Overall, current research indicates that magnesium sulfate is a safe option for treating asthma in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike standard asthma treatments that often involve inhaled beta agonists and IV steroids, magnesium sulfate is being investigated as an early intervention for asthma exacerbations. Researchers are excited about magnesium sulfate because it works by relaxing the muscles around the airways and reducing inflammation, potentially providing rapid relief within the first hour of treatment. This could be particularly beneficial in acute settings where fast action is crucial. If successful, it would add a novel option to the existing asthma management toolkit, giving healthcare providers an additional method to quickly stabilize patients during severe asthma attacks.

What evidence suggests that magnesium sulfate might be an effective treatment for childhood asthma?

Research has shown that magnesium sulfate can help children with severe asthma attacks. In this trial, one group of participants will receive magnesium sulfate through an IV within the first hour of treatment. Studies have found that this approach can help children breathe easier and reduce the need for hospital stays. It is considered safe and might lower the chances of needing more serious treatments later. Administering magnesium sulfate early in the treatment process appears to prevent hospital admissions and shorten time spent in emergency care. This treatment works alongside other asthma medications to improve outcomes. ^{1 4 6 7 8}

Who Is on the Research Team?

Ryan McKee, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Patients who are pregnant

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

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.

How Is the Trial Designed?

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 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

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

In a study involving 508 children with severe acute asthma, nebulised magnesium sulphate (MgSO4) showed a statistically significant reduction in asthma severity scores compared to placebo, but the difference was not clinically significant overall.

The most notable benefits of MgSO4 treatment were observed in children with more severe asthma exacerbations and those whose symptoms had lasted less than 6 hours, indicating potential targeted efficacy in specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Powell, C., Kolamunnage-Dona, R., Lowe, J., et al.[2014]

In a study involving 90 children aged 6-14 with acute asthma, the addition of nebulized magnesium sulfate (MgSO4) to salbutamol did not lead to significant improvements in lung function, as measured by peak expiratory flow rate (PEFR).

While both treatment groups showed a decrease in heart rate and improvements in oxygen saturation (SpO2), these changes were not statistically significant, indicating that MgSO4 may not provide additional benefits in managing acute asthma in this pediatric population.

NCBI (Pubmed)

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. Siddiqui, H., Siddiqui, SA., Yadav, RK., et al.[2022]

In a study of 54 children with moderate to severe asthma exacerbations, the administration of high-dose magnesium sulfate did not significantly improve asthma symptoms compared to a placebo, as measured by Pulmonary Index scores.

There was no notable difference in hospitalization rates or time to meet discharge criteria between the magnesium and placebo groups, indicating that magnesium sulfate may not be an effective routine treatment for acute asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. Scarfone, RJ., Loiselle, JM., Joffe, MD., et al.[2006]

In a study involving 508 children aged 2-15 with acute severe asthma, nebulised magnesium sulphate (MgSO4) showed a statistically significant improvement in asthma severity scores compared to placebo, particularly in children with more severe exacerbations and shorter symptom duration.

The addition of nebulised MgSO4 to standard asthma treatment (salbutamol and ipratropium bromide) was found to be safe, with no significant adverse effects, and may be cost-effective for the NHS, suggesting it could be a beneficial adjunct therapy in managing acute asthma episodes.

NCBI (Pubmed)

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. Powell, CV., Kolamunnage-Dona, R., Lowe, J., et al.[2022]

A review of 8 studies involving 447 children found that prolonged magnesium sulfate infusions (over 1 hour) are used for treating refractory asthma, but most studies did not assess clinical outcomes like lung function or hospital admissions.

While magnesium sulfate infusions were generally safe, with only 1.1% of patients experiencing high magnesium levels, adverse events such as hypotension and nausea were more common in those receiving infusions lasting over 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Magnesium Sulfate Infusions for Status Asthmaticus in Children: A Systematic Review. Johnson, PN., Drury, AS., Gupta, N.[2022]

A review of 16 studies indicates that intravenous bolus magnesium sulphate is safe for treating children with acute severe asthma in non-critical care settings.

Safety measures, such as line of sight nursing and cardiorespiratory monitoring, are essential when administering magnesium sulphate to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? de Havilland, A., Hariharan, G., Puvvadi, R.[2022]

Magnesium sulfate can be beneficial for asthmatic patients who do not respond well to initial treatments like beta-agonists and corticosteroids, potentially acting as a calcium antagonist and aiding in ion flux across cell membranes.

While routine use of magnesium sulfate in emergency departments for acute asthma is not recommended, it may provide some benefits as an adjunct therapy for severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the intravenous and nebulized magnesium sulfate for the treatment of the acute asthma in the emergence]. Barbosa, FT., Barbosa, LT., Cunha, RM., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497407/

Magnesium Sulfate in Pediatric Emergency Medicine Contemporary evidence supports the use of intravenous MgSO₄ in children presenting with acute severe asthma, with multiple randomized controlled ...

2. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6179

Pharmacokinetics and Pharmacodynamics of Intravenous ... The findings signal that IVMg may be an efficacious and safe option for treating moderate–severe pediatric acute asthma exacerbations in the ED.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acem.70006

Prompt use for Asthma in Children Treated in the ... Intravenous magnesium sulfate (IVMg) may reduce hospitalization in children with asthma when given in addition to other standard medications, ...

4. researchgate.net researchgate.net/publication/391743610_A_comparative_analysis_of_the_effectiveness_of_Magnesium_Sulfate_in_treating_acute_bronchial_asthma_in_children_Nebulized_versus_intravenous_administration

A comparative analysis of the effectiveness of Magnesium ... A comparative analysis of the effectiveness of Magnesium Sulfate in treating acute bronchial asthma in children: Nebulized versus intravenous ...

5. researchgate.net researchgate.net/publication/339364220_Efficacy_of_Magnesium_Sulfate_Treatment_in_Children_with_Acute_Asthma

Efficacy of Magnesium Sulfate Treatment in Children with ... The aim of the study was to evaluate whether intravenous (IV) MgSO4 improves lung function measurements in children with acute asthma. Methods: ...

6. cochrane.org cochrane.org/evidence/CD003898_inhaled-magnesium-sulfate-safe-and-effective-treatment-people-asthma-attacks

Is inhaled magnesium sulfate a safe and effective treatment ... We found that adding inhaled magnesium sulfate to standard treatments may result in small benefits in terms of lung function, hospital admission and severity ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39775569/

Pharmacokinetics and Pharmacodynamics of Intravenous ... The findings signal that IVMg may be an efficacious and safe option for treating moderate-severe pediatric acute asthma exacerbations in the ED.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11584261/

Safety and Effectiveness of Prolonged Magnesium Sulfate ... Prolonged MgSO 4 infusion is safe at a maximum dose of 30 mg/kg/h and may be beneficial for children with asthma exacerbation.