Paediatric accelerator mass spectrometry evaluation research study
| ISRCTN | ISRCTN24569018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24569018 |
| Protocol serial number | 1.0 |
| Sponsor | Liverpool Women's NHS Foundation Trust (UK) |
| Funder | ERA-NET PrioMedChild (Priority Medicines for Children) (Netherlands) |
- Submission date
- 22/10/2012
- Registration date
- 27/11/2012
- Last edited
- 24/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is an urgent need to ensure that medicines given to children are assessed sufficiently. A range of methods have been proposed to do this. The aim of the study is to apply and test a method called microtracer dosing with accelerator mass spectrometry (AMS) bioanalysis, using paracetamol as a model drug and find out its effects on newborn, infants and toddlers. The results are compared with the information available in previous research that used standard methods. This study could establish a way for AMS studies to be a part of Paediatric Investigation Plans for development of new drugs. This will mean that new drugs can be given to children earlier than in current practice.
Who can participate?
Male and female hospitalised infants aged between preterm up to 2 years
What does the study involve?
A single microdose of radioactive paracetamol will be given to infants whose age range is preterm up to 2 years of age orally or injected through the vein. A maximum of 20 extra drops of blood is taken from each participant. This is spread over the 12 hours after the isotope dose is received. The total amount of blood taken will be 1ml. The blood is taken via the lines already in place. The maximum length of participation in the study is up to 48 hours after giving the study drug.
What are the possible benefits and risks of participating?
The participants will not gain any direct benefit. The benefits from this study are for other babies in the future as the information gathered in this study becomes available. The risks due to paracetamol will be minimal as this microdose is less than a millionth of the dose normally given to newborn babies and infants. There are no anticipated safety issues relating to exposure to the radioactive drug.
Where is the study run from?
1. Liverpool Womens NHS Foundation Trust, UK (lead centre)
2. Tartu University Hospital, Childrens Clinic, Estonia
3. Alder Hey Childrens NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
The study started in November 2012 and will run for 2 years.
Who is funding the study?
ERA-NET PrioMedChild (Priority Medicines for Children), Netherlands.
Who is the main contact?
Miss Louise Hardman
louise.hardman@lwh.nhs.uk
Contact information
Scientific
Liverpool Women's NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 795 9558 |
|---|---|
| mark.turner@liverpool.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre observational open-label study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | PAMS |
| Study objectives | 14C-labelled microdose paracetamol has similar PK to standard, therapeutic paracetamol. |
| Ethics approval(s) | NRES Committee North West - Liverpool East, 08/10/2012, ref: 12/NW/0675 |
| Health condition(s) or problem(s) studied | Medicines for Children; Paediatrics |
| Intervention | 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 be included in the data if they are taken 24 hours before the drug is administered in neonates and up to 3-7 days before for older infants. A maximum of 5 blood samples after drug administration will also be collected. Details of blood results that will be collected for the study data are: Biochemistry: Plasma creatinine, Na+, K+ Cl, AST, ALT, alkaline phosphatase, total bilirubin, conjugated bilirubin, albumin, total calcium, corrected calcium, magnesium, C-reactive protein. Full Blood Count: Hgb, total white cell count, differential white cell count, MCV, MCH, MCHC and platelets. Blood gas: pH, glucose, lactate, ionized calcium In participants with urinary catheters in place the urine collection bag will be emptied immediately before the microdose is administered. Timed samples of urine will be collected for 48 hours after the microdose is administered. |
| Intervention type | Other |
| Primary outcome measure(s) | A noncompartmental model of paracetamol disposition |
| Key secondary outcome measure(s) | A population model of the whole dataset taking account of all the variables |
| Completion date | 11/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/11/2012 |
| Date of final enrolment | 11/11/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
- Estonia
Study participating centre
L8 7SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2017: Publication reference added.
