Paediatric accelerator mass spectrometry evaluation research study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN24569018

Enrollment

Registered

2012-11-27

Start date

2012-11-12

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medicines for Children

Interventions

No specific study-related assessments will be conducted. No haematology, biochemistry or blood gas studies samples will be taken for the purposes of this study. The most recent blood samples will b

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
A noncompartmental model of paracetamol disposition	—

Secondary

Measure	Time frame
A population model of the whole dataset taking account of all the variables	—

Countries

Estonia, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026