ISRCTN16091879
Completed
未知
A multi-centre clinical study to evaluate the use of a microtrace dose of 14C-labelled midazolam and accelerator mass spectrometry (AMS) bioanalysis as new tools in drug development to determine pharmacokinetics in neonates, infants and toddlers
iverpool Women's NHS Foundation Trust (UK)0 sites25 target enrollmentJune 23, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Medicines for Children
- Sponsor
- iverpool Women's NHS Foundation Trust (UK)
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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