Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Parental satisfaction questionnaire
研究概览
简要总结
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 age
Intervention: There will be two groups:
- Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
- 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
详细描述
Urinary tract infection (UTI) is a common source of infection in children. It accounts for 5 to 14 percent of visits by children every year. The overall prevalence is around 7% among different age subgroups of children. Several factors affect the prevalence of UTI including age, gender, and circumcision status.
The diagnosis of UTI requires obtaining a urine specimen from the patient. Generally, there are four methods used in collecting urine samples which can be categorized as invasive (such as suprapubic aspiration and urethral bladder catheterization) and noninvasive (such as Sterile bag and clean catch).
The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not. In non-toilet-trained patients, urethral bladder catheterization or suprapubic aspiration can be used. The latter is having the least contamination rate in urine culture. Clean-catch urine is commonly used for toilet-trained patients. If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy, urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration.
Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique. In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization. According to American academy of pediatrics (AAP), for non-toilet trained children, it's advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration, especially when a sample obtained using a perineal bag shows positive results on a dipstick test. The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old, due to false positive results that can occur in the other urine collection techniques.
Urethral bladder catheterization carries a 6 to 12 percent of contamination rate. In regard clean catch urine method 16 to 63 percent of the contamination rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician who will analyze the data will be blinded.
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable infants.
- •Require urine collection as part of their work-up in the emergency department.
- •Age 0 to 6 months.
排除标准
- •Parental refusal.
- •Unstable hemodynamically young infants.
研究组 & 干预措施
Catheterization
Group A: is the control group, participant will undergo bladder catheterization. (The standard practice)
干预措施: Bladder catheterization (Procedure)
Clean Catch
Group B: is the experimental group, participant will undergo clean catch urine via bladder massage technique.
干预措施: clean catch urine via bladder massage technique (Procedure)
结局指标
主要结局
Parental satisfaction questionnaire
时间窗: After the procedure immediately
Parental satisfaction with the procedure techniques (in both arms) will be evaluated by a questionnaire.
Urine culture contamination rate
时间窗: After urine culture report (usually 2-3 days after urine collection)
Urine culture contamination rate will be evaluated in both techniques used in the study which includes dividing the total number of contaminated urine culture sets by the total number of urine culture.
次要结局
- duration of the procedure(during each procedure)
- Pain score(after the procedure immediately)
研究者
Sulayyem Saleh Al Harsousi
Principal Investigator
Oman Medical Speciality Board