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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Change in Prednisolone concentration levels as measured by ELISA

Timeframe: 0, 24, 48, 72, 96 hours after methylprednisolone dosing

Trial details

NCT IDNCT04874610

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-31

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