Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is to more rigorously evaluate the response to a single bolus of magnesium sulfate in a population of patients with moderate to severe bronchiolitis. The primary outcome will be to evaluate the effect of this therapy on clinical respiratory status. Secondary outcomes of interest will include the incidence of adverse effects and safety profile of magnesium bolus use in this population.

Detailed Description
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This randomized placebo-controlled pilot study is designed to evaluate the above referenced outcomes. Study drug initiation will occur in the local pediatric intensive care unit in patients with a clinical diagnosis of bronchiolitis and whose parent/LAR consents for their participation. Our goal is to enroll and evaluate a total of 40 patients. Upon obtaining informed consent, the participant will receive an enrollment history and physical to include: baseline Modified Pulmonary Index Score (MPIS), blood pressure, vital signs, and epidemiologic data. The participant will then receive either a bolus of 50mg/kg Magnesium Sulfate (MgSO4) or normal saline as placebo medication over twenty minutes. Vital signs and MPIS will be monitored according to the study schedule, for a total of six hours. During the period of monitoring subjects will not receive additional bronchodilators unless otherwise deemed clinically necessary by the subject's attending physician. If administered, these will be recorded by investigative team.

Official Title
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Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Conditions
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Bronchiolitis, Viral

Intervention / Treatment
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* Drug: Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants under 12 months of age Admitted to the pediatric intensive care unit Moderate/severe bronchiolitis using MPIS Less than 24 hours of admission to the PICU Parent/LAR consents for infant to participate Exclusion Criteria: Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized placebo-controlled pilot study with 1:1 randomization
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Sulfate<br>The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes. | Drug: Magnesium Sulfate<br>* Randomized to receive either magnesium sulfate or normal saline placebo.<br>|
| Placebo Comparator: Placebo<br>The patient will receive a bolus of Normal Saline over twenty minutes. | Drug: Magnesium Sulfate<br>* Randomized to receive either magnesium sulfate or normal saline placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of this therapy on clinical respiratory status | MPIS will be used to follow respiratory status | 6 hours post bolus of medication versus placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the incidence of adverse effects and safety profile of magnesium sulfate | Patients will be followed for any potential adverse events. | 6 hours post bolus of medication versus placebo |