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Electrolyte

Magnesium Sulfate for Bronchiolitis

Phase 2 & 3
Waitlist Available
Led By John W Berkenbosch, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 24 hours of admission to the PICU
Admitted to the pediatric intensive care unit
Must not have
Patients with unrepaired congenital heart disease
Patients with chronic lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours post bolus of medication versus placebo

Summary

This trial will evaluate the effect of magnesium sulfate on bronchiolitis, a common respiratory illness in infants.

Who is the study for?
This trial is for infants under 12 months old with moderate to severe bronchiolitis, admitted to the pediatric intensive care unit within the last 24 hours. Parents must consent for their child's participation. Infants with cyanotic heart disease, chronic lung disease, or unrepaired congenital heart disease cannot participate.
What is being tested?
The study tests how a single dose of magnesium sulfate affects infants with bronchiolitis in terms of breathing and overall respiratory health. It also looks at any side effects and safety concerns associated with this treatment.
What are the potential side effects?
While not specified here, common side effects of magnesium sulfate may include flushing, sweating, lowered blood pressure, confusion, and slowed breathing in some cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was admitted to the Pediatric Intensive Care Unit less than 24 hours ago.
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I am currently in the pediatric intensive care unit.
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My child is under 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition from birth that hasn't been fixed.
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I have a long-term lung condition.
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I have a heart condition that causes bluish skin from poor circulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours post bolus of medication versus placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours post bolus of medication versus placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the effect of this therapy on clinical respiratory status
Secondary study objectives
Identify the incidence of adverse effects and safety profile of magnesium sulfate

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510
30%
Pain with injection of propofol
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium SulfateExperimental Treatment1 Intervention
The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.
Group II: PlaceboPlacebo Group1 Intervention
The patient will receive a bolus of Normal Saline over twenty minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium Sulfate
2011
Completed Phase 4
~4110

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
346 Previous Clinical Trials
77,525 Total Patients Enrolled
1 Trials studying Bronchiolitis
72 Patients Enrolled for Bronchiolitis
John W Berkenbosch, MDPrincipal InvestigatorUniversity of Louisville

Media Library

Magnesium Sulfate (Electrolyte) Clinical Trial Eligibility Overview. Trial Name: NCT04740294 — Phase 2 & 3
Bronchiolitis Research Study Groups: Placebo, Magnesium Sulfate
Bronchiolitis Clinical Trial 2023: Magnesium Sulfate Highlights & Side Effects. Trial Name: NCT04740294 — Phase 2 & 3
Magnesium Sulfate (Electrolyte) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740294 — Phase 2 & 3
~6 spots leftby Jun 2025
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