{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:53:42Z","timestamp":1792788822689,"version":"4.5.0"},"reference-count":43,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Institute for Health and Care Research (NIHR) Health Technology Assessment","award":["NIHR156005"],"award-info":[{"award-number":["NIHR156005"]}],"id":[{"id":"https:\/\/ror.org\/0187kwz08","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>\n                    Background Urinary tract infections (UTI) are the second most common serious bacterial infection in children. When healthcare practitioners are unsure if an infant, child, or young person has a UTI they perform a urine test. A midstream sample is recommended by the National Institute for Health and Care Excellence (NICE) for obtaining urine for testing. However, collecting urine from children who are unable to provide a midstream urine sample is challenging. Samples can be collected either by non-invasive (clean catch) or invasive methods (trans-urethral bladder catheter or suprapubic aspirate). Non-invasive methods are slow and prone to contamination but are painless. Invasive methods are less prone to contamination and are quick but can cause pain and distress. Methods This is a mixed methods feasibility study comprising of three parts. Part 1 is a pragmatic multicentre randomised controlled feasibility trial. The trial aims to evaluate the feasibility of conducting an RCT comparing invasive and non-invasive sampling methods for infants, children and young people (N = 100). Resource use will be assessed by parent reported questionnaire and mixed methods descriptors reported by healthcare professionals (n = 24). A cost analysis will assess the urine collection methods, informing a future cost-effectiveness analysis. Part 2 is an embedded mixed methods perspectives\u2019 study including interviews with parents (n = 15-20) and children (n = 10-15), five focus groups (n = 6-8 per group) and interviews (n = 10) with healthcare professionals aiming to assess feasibility and acceptability of the trial. Part 3 is a stakeholder (n = 40) consensus meeting determining a final definitive study design. Discussion The results of the study will inform a recommendation and decision on progression and design of a definitive RCT for infants, children and young people who have a suspected urine infection but cannot provide a midstream urine sample. Trial registration International Standard Randomised Controlled Trial Number (ISRCTN) 84676764: Feasibility of conducting a randomised controlled trial (RCT) comparing invasive and non-invasive urine sampling techniques in children under 16 years old with a suspected urinary tract infection\n                    <ns3:sup>1<\/ns3:sup>\n                    .\n                  <\/ns3:p>","DOI":"10.3310\/nihropenres.14114.1","type":"journal-article","created":{"date-parts":[[2025,11,23]],"date-time":"2025-11-23T12:15:07Z","timestamp":1763900107000},"page":"108","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Determining the feasibility of randomising infants, children and young people to invasive and non-invasive urine sampling techniques (FROG): Protocol for a multicentre randomised controlled feasibility trial and mixed methods perspectives\u2019 study of RCT 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Chan","year":"2013","journal-title":"BMJ."},{"key":"ref-28","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-023-10011-x","article-title":"Development of a brief, generic, Modular Resource-Use Measure (ModRUM): piloting with patients.","volume":"23","author":"K Garfield","year":"2023","journal-title":"BMC Health Serv Res."},{"key":"ref-29","doi-asserted-by":"publisher","DOI":"10.1037\/t05183-000","article-title":"Subjective Units of Distress Scale (SUDS).","author":"J Wolpe","year":"1969"},{"key":"ref-30","doi-asserted-by":"crossref","article-title":"Wong-Baker FACES pain rating scale.","author":"D Wong","DOI":"10.1037\/t05330-000"},{"key":"ref-31","first-page":"293-7","article-title":"The FLACC: a behavioural scale for scoring postoperative pain in young children.","volume":"23","author":"S Merkel","year":"1997","journal-title":"Pediatr Nurs."},{"key":"ref-32","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-14-45","article-title":"How experience makes a difference: practitioners\u2019 views on the use of deferred consent in paediatric and neonatal emergency care trials.","volume":"14","author":"K Woolfall","year":"2013","journal-title":"BMC Med Ethics."},{"key":"ref-33","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-075823","article-title":"Applying Clinical Decision Aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland: Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study protocol.","volume":"13","author":"E Umana","year":"2023","journal-title":"BMJ Open."},{"key":"ref-34","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-023-46232-7","article-title":"Selective digestive tract decontamination to prevent healthcare associated infections in critically ill children: the PICNIC multicentre randomised pilot clinical trial.","volume":"13","author":"N Pathan","year":"2023","journal-title":"Sci Rep."},{"key":"ref-35","doi-asserted-by":"publisher","first-page":"1-148","DOI":"10.3310\/hta23050","article-title":"Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT.","volume":"23","author":"M Peters","year":"2019","journal-title":"Health Technol Assess."},{"key":"ref-36","doi-asserted-by":"publisher","first-page":"1-106","DOI":"10.3310\/hta22510","article-title":"Restricted fluid bolus versus current practice in children with septic shock: the FiSh feasibility study and pilot RCT.","volume":"22","author":"D Inwald","year":"2018","journal-title":"Health Technol Assess."},{"key":"ref-37","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2024-085142","article-title":"Developing an adaptive paediatric Intensive Care Unit platform trial with key stakeholders: a qualitative study.","volume":"15","author":"T Mitchell","year":"2025","journal-title":"BMJ Open."},{"key":"ref-38","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-077023","article-title":"Stakeholders\u2019 perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study.","volume":"14","author":"E Deja","year":"2024","journal-title":"BMJ Open."},{"key":"ref-39","doi-asserted-by":"publisher","first-page":"1-84","DOI":"10.3310\/HDKV1008","article-title":"Use of selective gut decontamination in critically ill children: PICnIC a pilot RCT and mixed-methods study.","volume":"28","author":"A Brown","year":"2024","journal-title":"Health Technol Assess."},{"key":"ref-40","doi-asserted-by":"publisher","first-page":"49-53","DOI":"10.1136\/archdischild-2015-309245","article-title":"Fifteen-minute consultation: research without prior consent (deferred consent) in emergency medicine.","volume":"101","author":"K Woolfall","year":"2016","journal-title":"Arch Dis Child Educ Pract Ed."},{"key":"ref-41","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2014-005045","article-title":"Doing challenging research studies in a patient-centred way: a qualitative study to inform a Randomised Controlled Trial in the paediatric emergency care setting.","volume":"4","author":"K Woolfall","year":"2014","journal-title":"BMJ Open."},{"key":"ref-42","article-title":"Emergency research without prior consent: ethical implications of deferred consent in paediatric emergency care.","volume":"17","author":"K Woolfall","year":"2013","journal-title":"Crit Care."},{"key":"ref-43","article-title":"SPIRIT CHECKLIST FROG Study.","author":"P Miller","year":"2025","journal-title":"OSF"}],"container-title":["NIHR Open 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Award ID: NIHR156005.  The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.\u00a0. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}