Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT04740294

Collaborator

(none)

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis, Viral	Drug: Magnesium Sulfate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To evaluate the effect of this therapy on clinical respiratory status [6 hours post bolus of medication versus placebo]
MPIS will be used to follow respiratory status

Secondary Outcome Measures

Identify the incidence of adverse effects and safety profile of magnesium sulfate [6 hours post bolus of medication versus placebo]
Patients will be followed for any potential adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norton Children's Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: John W Berkenbosch, MD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John W Berkenbosch, Professor, University of Louisville

ClinicalTrials.gov Identifier:

NCT04740294

Other Study ID Numbers:

20.1171

First Posted:

Feb 5, 2021

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bronchiolitis

Bronchiolitis, Viral

Magnesium Sulfate

Study Results

No Results Posted as of Jan 5, 2022