Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

NCT ID: NCT04740294

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2025-07-01

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.

Conditions

Bronchiolitis, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Magnesium Sulfate

The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.

Group Type: EXPERIMENTAL

Magnesium Sulfate

Intervention Type: DRUG

Randomized to receive either magnesium sulfate or normal saline placebo.

Placebo

The patient will receive a bolus of Normal Saline over twenty minutes.

Group Type: PLACEBO_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

Randomized to receive either magnesium sulfate or normal saline placebo.

Interventions

Magnesium Sulfate

Randomized to receive either magnesium sulfate or normal saline placebo.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

John W Berkenbosch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John W Berkenbosch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Norton Children's Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

20.1171

Identifier Type: -

Identifier Source: org_study_id