Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus (NCT04929626) | Clinical Trial Compass
CompletedPhase 1
Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus
Pakistan126 participantsStarted 2022-01-01
Plain-language summary
In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.
Who can participate
Age range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children between 2 to 12 years of age.
. Children with the diagnosis of asthma having a pram score of more than 4.
. Children with reactive airways
Exclusion criteria
. Critically ill children who require intubation or mechanical ventilation.
. Having hypersensitivity or allergy to MgSO4.
. with history of chronic lung impairment.
. Whose parents are not giving informed consent for participation in research.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial testing different doses of nebulized magnesium sulphate in children with status asthmaticus, what do the results tell us so far about which dose seemed safest, and how does being an early-phase study affect how much we can trust those findings?
2The trial measured breathing improvements like wheezing, air entry, and oxygen saturation — based on what this study found, does nebulized magnesium sulphate seem to work well enough compared to the standard emergency treatments my child would already receive?
3Status asthmaticus is a medical emergency, so could you walk me through how participating in a dose-finding trial like this one might have affected what immediate treatments a child received, and whether that raises any concerns for our situation?
4Now that this trial is completed, are the results published or available anywhere, and would those findings change how you might approach treatment if my child has a severe asthma attack?
5Are there other ongoing or more advanced trials — or already approved treatments — that might be a better fit to discuss given that this was only a Phase 1 dose-finding study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
2
Change from baseline Suprasternal indrawing
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
3
Change from baseline Scalene retractions
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
4
Change from baseline Wheezing
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
5
Change from baseline Air entry
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
6
Change from baseline Oxygen saturation on room air
Timeframe: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment