Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

NCT04740294 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20.1171
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis, Viral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify the incidence of adverse effects and safety profile of magnesium sulfate

  6 hours post bolus of medication versus placebo

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Placebo

PLACEBO COMPARATOR

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

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

Randomized to receive either magnesium sulfate or normal saline placebo.

Magnesium Sulfate; Placebo

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Bronchiolitis, Viral

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• John W Berkenbosch, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be done in the pharmacy using a pre-developed randomization table. Study medication, whether MgSO4 or placebo, will be prepared by a study pharmacist and sent to the nursing/clinical staff for administration labelled as "study drug". Unblinding, if clinically indicated, can be provided to the treatment team but it is not anticipated that this will be required.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized placebo-controlled pilot study with 1:1 randomization

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: July 21, 2021
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)