protocolSection identificationModule nctId: NCT06265142, orgStudyIdInfo id: MoH/CSR/23/26368, briefTitle: Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, descriptionModule briefSummary: Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.Patient Population: young infants from 0 to 6 months of ageIntervention: There will be two groups:1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.Outcome: Contamination rate and feasibility of both urine sampling techniques, conditionsModule conditions: Urinary Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B, after collecting urine by CCU, we recommend to collect another sample by catheterization to guide the management and antibiotic choice., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The statistician who will analyze the data will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bladder catheterization, interventions name: clean catch urine via bladder massage technique, outcomesModule primaryOutcomes measure: Urine culture contamination rate, primaryOutcomes measure: Parental satisfaction questionnaire, secondaryOutcomes measure: duration of the procedure, secondaryOutcomes measure: Pain score, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 6 Months, stdAges: CHILD, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-01, uploadDate: 2024-02-14T09:44, filename: Prot_000.pdf, size: 662911, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-01, uploadDate: 2024-02-14T09:45, filename: ICF_001.pdf, size: 128074, hasResults: False