Feasibility of randomising children to urine sampling (FROG) V1.0
Research type
Research Study
Full title
Determining the feasibility of randomising children and young people to invasive and non-invasive urine sampling techniques (FROG): A pragmatic multi centred randomised controlled feasibility trial and a mixed methods feasibility perspectives study
IRAS ID
339327
Contact name
Tom Waterfield
Contact email
Sponsor organisation
Queens University Belfast
Duration of Study in the UK
1 years, 1 months, 23 days
Research summary
Internationally, the approach to urine collection varies. In Europe and North America, national guidelines favour invasive urine collection methods, given their advantage of much lower rates of bacterial contamination.
When healthcare practitioners rely on non-invasive urine sampling to diagnose UTI, antibiotic prescribing rates are increased, because of false positive urine test and culture results from contaminated samples. Bacterial contamination impacts patients and families through unnecessary follow up, painful investigations, and admission to hospital even though they do not have a UTI.
A UK based study is required to determine which invasive or non-invasive urine sampling methods infants, children, and young people should be offered. However, a feasibility study is required to determine if a definitive RCT would be acceptable and possible to conduct and, if so, to inform its design.
This NIHR funded study is a mixed methods design including three work packages:
Work package 1 is a UK six centre pragmatic multicentre randomised controlled feasibility trial (n = 100) including EDs, assessment units, inpatient wards, and outpatient clinics. The trial will assess the feasibility of randomising children (<16 years) who are not toilet trained and require testing for a suspected UTI to invasive and non-invasive urine sampling.
Work package 2 is a mixed methods perspectives study including questionnaire, interviews and focus groups exploring parent/guardian, children’s and healthcare professional’s views and acceptability of the proposed study and sampling methods. This will include parents/guardians and children (aged 7-15 years) who are approached to participate in WP1 (including decliners), as well as parents and children with relevant experience recruited through social media. Healthcare practitioners will include those who are and are not involved in recruitment to WP1.
Work package 3 involves a consensus meeting with key stakeholders (from WP1, 2 and wider networks) to discuss a final definitive study design.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0222
Date of REC Opinion
13 Feb 2025
REC opinion
Further Information Favourable Opinion