Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus (NCT04874610) | Clinical Trial Compass
CompletedNot Applicable
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
United States15 participantsStarted 2021-08-16
Plain-language summary
Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.
Who can participate
Age range
2 Years – 20 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
. Age between 2 years and 20 years inclusive
. Written informed consent provided by a parent or legal guardian
. Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
. BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects
Exclusion criteria
. Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
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.
1This study looked at how obese and non-obese children metabolize prednisolone differently during a severe asthma attack — could my child's weight affect how well prednisolone works for them during an asthma flare-up?
2Since this trial has already been completed, has my doctor seen or heard about any findings from it that might change how prednisolone dosing is approached for children with obesity and asthma?
3If prednisolone is metabolized differently in obese children, should we be discussing whether my child's current asthma treatment plan accounts for their weight when steroid doses are prescribed?
4This study was observational and focused on measuring drug levels rather than testing a new treatment — does that mean it's more about understanding a problem than offering a new solution, and what would the next steps be if the findings are significant?
5Are there any current standard-of-care guidelines that already adjust steroid dosing based on a child's weight during status asthmaticus, or is that something doctors are still figuring out?
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 Prednisolone concentration levels as measured by ELISA
Timeframe: 0, 24, 48, 72, 96 hours after methylprednisolone dosing