A Phase 2/3 interventional study of Magnesium Sulfate in Bronchiolitis, Viral, sponsored by University of Louisville. Withdrawn at 1 site in United States. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Louisville · Phase 2/3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.
Drug: Magnesium Sulfate
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.
To evaluate the effect of this therapy on clinical respiratory status
MPIS will be used to follow respiratory status
Time frame: 6 hours post bolus of medication versus placebo
Identify the incidence of adverse effects and safety profile of magnesium sulfate
Patients will be followed for any potential adverse events.
Time frame: 6 hours post bolus of medication versus placebo
Plan to share: No — The information will not be shared outside of the University except as de-identified data for presentation of results virtually or in print.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of Louisville