Paediatric Accelerator Mass Spectrometry evaluation research study (midazolam)
Not Applicable
Completed
- Conditions
- Medicines for ChildrenPaediatricsNot Applicable
- Registration Number
- ISRCTN16091879
- Lead Sponsor
- iverpool Women's NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
1. Infants and toddlers from preterm neonates (32-36 GW at birth) up to 2 years
2. Having intravenous or intra-arterial access suitable for blood sampling
3. Written informed consent prior to any study-specific procedures
4. For dried blood spot sampling in addition to plasma, the participant must weigh more than 2.3 kg
Exclusion Criteria
1. History of allergy or hypersensitivity to midazolam
2. Serious hepatic and/or renal impairment defined as creatinine > 150 micromol or AST or ALT > 200
3. Be otherwise unsuitable for the study, in the opinion of the investigator
4. Extracorporeal membrane oxygenation (ECMO)
5. Haemofiltration, peritoneal dialysis, haemodialysis
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study will be a noncompartmental model of midazolam disposition
- Secondary Outcome Measures
Name Time Method The secondary outcome will be a population model of the whole dataset taking account of all the variables. Pharmacogenetic outcomes will relate continuous variables (midazolam or metabolism concentrations at steady state) with the presence of polymorphisms in CYP3A4