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 range2 Years – 20 Years

SexALL

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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.

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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