Pediatric Microdosing midazolam: elucidating age-related changes in oral drug absorptio
- Conditions
- Midazolam, ontogeny, children, absoprtion, metabolism.
- Registration Number
- NL-OMON26131
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Age 0 to 6 years inclusive - At least 36 weeks of post conceptual age or bodyweight >2,5kg - Intravenous or intra-arterial access for blood sampling in place - Receiving midazolam IV - Parental informed consent
Anticipated death in 48 hours - No informed consent - ECMO treatment - Circulatory failure: receiving more than 1 vasopressor or increase of vasopressor drug dose in the last 6 hours. - Chronic liver cirrhosis or chronic renal failure - Renal disorders: Estimated risk for kidney injury or failure at least ‘risk for renal dysfunction’ according to pRIFLE criteria - Hepatic failure: >2SD in age appropriate liver enzyme measurement (ASAT and ALAT) - Gastrointestinal disorderse - Use of co-medication known to affect midazolam metabolism (according to the Farmacotherapeutische Kompas, www.fk.cvz.nl, and Micromedex)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma midazolam to midazolam and metabolite clearance, as surrogate marker of CYP3A activity in vivo
- Secondary Outcome Measures
Name Time Method The following parameters will be estimated for both formulations: midazolam and metabolite plasma and urinary clearance, volume of distribution, AUC, Cmax, Tmax. In feces: midazolam and metabolite appearance. Oral bioavailability of midazolam. Description of the feasibility of a microdosing study in a pediatric population.