None listed
Conditions
Brief summary
This is a single-centre, prospective randomized controlled trial aimed at evaluating the feasibility of using sterile cotton balls as an alternative method for urine collection in non-toilet-trained children. The study compares sterile cotton balls with the standard paediatric urine bag in terms of time required to obtain a sample, cost-effectiveness and contamination rates. Participants, aged 0 to 36 months and admitted to the paediatric or neonatal ward, will be recruited using convenience sampling after obtaining informed parental consent. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group (sterile cotton balls) or control group (urine bag) through block randomization. It is hypothesised that urine collection using sterile cotton balls is more feasible than using urine bags, offering advantages in terms of collection time, cost and contamination rates.
Interventions
All participants will be divided into two study arms: • Arm 1 (Intervention Group): Urine collection using sterile cotton balls. • Arm 2 (Control Group): Urine collection using a paediatric urine bag. All admitted patients in the paediatric ward will be assessed for eligibility. Those who meet the inclusion criteria and whose parents or guardians provide written informed consent will be recruited into the study. The intervention material consists of sterile cotton balls. Three sterile cotton balls will be placed in the child’s diaper and left in situ until urine passage is detected. Passage of urine will be checked every 10 minutes by inspection of the diaper. If urine is not passed within 30 minutes, the cotton balls will be replaced, and the procedure will be repeated until urine is passed. Parents or caregivers will be briefly instructed about the procedure, including the purpose of the cotton balls, the need to keep the diaper in place and to immediately inform the medical staff if they notice urine passage or if the child becomes uncomfortable. Parents will not be required to manipulate or remove the cotton balls themselves. Adherence to the intervention will be ensured through direct supervision by the principal investigator or trained medical staff, who will place the cotton balls, perform scheduled checks every 10 minutes, and remove the cotton balls once urine is passed. The procedure will be conducted in a face-to-face manner and participants will be continuously monitored until a urine sample is successfully collected. The principal investigator, who has six years of experience in paediatrics, will oversee all procedures. Each participant will undergo the procedure once. Urine collection procedures in both groups will be performed within the ward setting.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients aged 0 to 36 months who are non-toilet trained and admitted to the paediatric or neonatal ward
Exclusion criteria
-Patient with UTI or suspected UTI -Patient with current diarrhea -Patient who previously already recruited in the study