NCT04740294

Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bronchiolitis, Viral

Interventions

Type	Name	Description
DRUG	Magnesium Sulfate	Randomized to receive either magnesium sulfate or normal saline placebo.

Timeline

• Start date: 2021-07-21
• Primary completion: 2025-06-30
• Completion: 2025-07-01
• First posted: 2021-02-05
• Last updated: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study