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Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Bronchiolitis, Viral Clinical Trial

Official title:
Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04740294
Study type Interventional
Source University of Louisville
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date July 21, 2021
Completion date July 1, 2025
View Details
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