Bronchiolitis, ViralPhase 2/3NCT04740294
Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
A Phase 2/3 study testing Magnesium Sulfate in people with Bronchiolitis, Viral, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 11 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Norton Children's Hospital
Louisville, Kentucky, 40202
About this study
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.
Read the 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
- Being tested
- Magnesium Sulfate
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Randomized to receive either magnesium sulfate or normal saline placebo.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Experimental | The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes. Receives: Drug: Magnesium Sulfate |
| Placebo | Placebo comparator | The patient will receive a bolus of Normal Saline over twenty minutes. Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of this therapy on clinical respiratory status
MPIS will be used to follow respiratory status
Measured: 6 hours post bolus of medication versus placebo
Secondary outcomes (1)
Identify the incidence of adverse effects and safety profile of magnesium sulfate
Patients will be followed for any potential adverse events.
Measured: 6 hours post bolus of medication versus placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start21 Jul 2021
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Why it stopped: unable to enroll any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized placebo-controlled pilot study with 1:1 randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W Berkenbosch, University of Louisville
- Investigators
- John W Berkenbosch, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740294
- Sponsor's protocol ID
- 20.1171
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The information will not be shared outside of the University except as de-identified data for presentation of results virtually or in print.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
- ClinicalTrials.gov ID
- NCT04740294
- Acronym / sponsor ID
- 20.1171
- Conditions
- Bronchiolitis, Viral
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized placebo-controlled pilot study with 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Experimental | Drug: Magnesium SulfateThe patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes. |
| Placebo | Placebo comparator | Drug: Magnesium SulfateThe patient will receive a bolus of Normal Saline over twenty minutes. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateRandomized to receive either magnesium sulfate or normal saline placebo. | Drug | Magnesium Sulfate, Placebo |
Primary outcome
To evaluate the effect of this therapy on clinical respiratory status
Time frame: 6 hours post bolus of medication versus placebo
MPIS will be used to follow respiratory status
1 secondary outcome
Identify the incidence of adverse effects and safety profile of magnesium sulfate
Time frame: 6 hours post bolus of medication versus placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. The information will not be shared outside of the University except as de-identified data for presentation of results virtually or in print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Berkenbosch, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium Sulfate in people with Bronchiolitis, Viral, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of this therapy on clinical respiratory status (time frame: 6 hours post bolus of medication versus placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.