Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- volume of urine collection to measure the effectiveness of two techniques
研究概览
简要总结
Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness.
According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children.
Recently, two quick, safe and effective methods have been reported in the literature:
- The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.
- The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.
However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.
详细描述
Urinary tract infections (UTI) are common in infants. The diagnosis of a UTI has important implications for follow-up, and delayed treatment can result in morbidity, including renal scarring and serious bacterial infection.
Obtaining urine from pre-continent children can be difficult and time consuming, the method of collection must balance reliability, speed, low rate of contamination, and invasiveness The actual guidelines recommend suprapubic aspiration or bladder catheterization for collection of urine sample in pre-continent children, but these methods are invasive.
The most common way to collect urines in infants is the use of a sterile collection bag. This is an easy technique, but time consuming and responsible for high rate of contamination, leading to false positives.
According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infection. However, it is impractical in pre-continent children.
Recently, two quick, safe and effective methods have been reported in the literature:
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
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants under the age of 1 year, pre-continent, before walking
- •For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
- •Obtaining the authorization by one of the two parents or the holder of parental authority
- •Affiliation to a national social security scheme
排除标准
- •Do exhibiting signs of vital distress
- •Withdrawal of informed consent by parents or holders of parental authority
- •External genitalia or urinary tract malformation
- •Bladder dysfunction
结局指标
主要结局
volume of urine collection to measure the effectiveness of two techniques
时间窗: at the end of intervention completion, an average 30 minutes
measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes
次要结局
- time needed to obtain urines(at the end of intervention completion, an average 30 minutes)
- patient comfort(through intervention completion, an average 30 minutes)
- collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques(through intervention completion, an average 30 minutes)
- Bacterial contamination rates of urine samples(at 48 hours after inclusion)