Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Phase 2

Active, not recruiting

• Conditions: Bronchiolitis, Viral
• Interventions: Drug: Magnesium Sulfate

• Registration Number: NCT04740294
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Study Start: 2021-07-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate	Magnesium Sulfate	The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.
Placebo	Magnesium Sulfate	The patient will receive a bolus of Normal Saline over twenty minutes.

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of this therapy on clinical respiratory status	6 hours post bolus of medication versus placebo	MPIS will be used to follow respiratory status

Secondary Outcome Measures

Name	Time	Method
Identify the incidence of adverse effects and safety profile of magnesium sulfate	6 hours post bolus of medication versus placebo	Patients will be followed for any potential adverse events.

Trial Locations

Locations (1)

Norton Children's Hospital; 🇺🇸 Louisville, Kentucky, United States