Medicines for Children
Conditions
Interventions
1. A single 14C labelled microdose of midazolam will be administered IV or orally. The microdose will contain 111 Bq / kg 14C labelled midazolam. The 14C labelled microdose of midazolam will be presen
Sponsors
Liverpool Women's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be a noncompartmental model of midazolam disposition | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed