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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04740294
• Other study ID #: 20.1171
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 21, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Drug:
• Magnesium Sulfate
Randomized to receive either magnesium sulfate or normal saline placebo.

Locations

Country	Name	City	State
United States	Norton Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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