Status:
COMPLETED
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
Lead Sponsor:
Duke University
Conditions:
Pediatric Obesity
Asthma in Children
Eligibility:
All Genders
2-20 years
Brief 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.
Detailed Description
This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04874610
Start Date
August 16 2021
End Date
March 31 2022
Last Update
July 1 2022
Active Locations (1)
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1
Duke University Hospital
Durham, North Carolina, United States, 27705