Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiolitis, Viral
• Intervention / Treatment: Drug: Magnesium Sulfate

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: John W Berkenbosch, MD; Phone Number: 502-852-3720; Email: john.berkenbosch@louisville.edu
• Study Contact Backup: Name: Janice Sullivan, MD; Phone Number: 502-629-5283; Email: sully@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: John W Berkenbosch, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 20.1171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The information will not be shared outside of the University except as de-identified data for presentation of results virtually or in print.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No