Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJuly 1, 2022
April 1, 2022
8 months
May 3, 2021
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Prednisolone concentration levels as measured by ELISA
Prednisolone levels at steady state concentration
0, 24, 48, 72, 96 hours after methylprednisolone dosing
Secondary Outcomes (1)
11-beta-hydroxysteroid dehydrogenase as measured by ELISA
Up to 72 hours after methylprednisolone dosing
Study Arms (2)
BMI > 95
Cohort 1: greater than or equal to 95%ile body mass index
BMI < 95
Cohort 2: less than 95%ile body mass index
Interventions
Administration of methylprednisolone Prescribed per Standard of care
Eligibility Criteria
Children and young adults 2-20 years of age who are admitted to Duke Hospital for primary reason of asthma exacerbation and are treated with methylprednisolone.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Hospital
Durham, North Carolina, 27705, United States
Biospecimen
Plasma from blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caitlin King, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 5, 2021
Study Start
August 16, 2021
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
July 1, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share