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Clinical Trials/ISRCTN24569018
ISRCTN24569018
Completed
未知

A multi-centre clinical study to evaluate the use of a microtrace dose of 14C-labelled paracetamol 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 sites60 target enrollmentNovember 27, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
iverpool Women's NHS Foundation Trust (UK)
Enrollment
60
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 27, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
iverpool Women's NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Infants and toddlers from preterm neonates (32\-36 GW at birth) up to 2 years of age
  • •2\. Having intravenous or intra\-arterial access suitable for blood sampling
  • •3\. Written informed consent prior to any study\-specific procedures
  • •4\. Able to tolerate oral administration for oral administration group

Exclusion Criteria

  • •1\. History of allergy or hypersensitivity to paracetamol;
  • •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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