A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Number of contaminated urine samples per SPA and UC
研究概览
简要总结
Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up to 10%.
Analysis of collected urine for the presence of bacteria or fungus is the only way to make a certain UTI diagnosis. Sterile collection of urine can be achieved in newborn infants by urinary catheterization (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean catch' where urine is collected into a sterile bottle as the baby urinates during preparation for UC. The main advantage of SPA is that it bypasses the bacteria that normally resides in the urethral opening, thus minimizing the risk of contamination. Some studies have suggested that SPA is better than UC for collecting urine in a sterile fashion in the neonate due to the difficulty of doing sterile UC in small infants resulting in more contaminated samples (also called a false-positive urine culture); there is still no clear best choice. UC is commonly used in many Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be done by the nursing staff, and generally has a higher chance of obtaining urine. SPA is a simple and safe alternative and, although it may be more painful than UC, it is performed more quickly. The reported success rate for SPA is variable, but is greatly increased when an ultrasound confirms urine in the bladder. The question remains: what is the best method for sterile collection of urine in neonates? In this study, the investigators will try to answer this question by collecting urine from neonates using either ultrasound guided SPA or UC and then comparing the contamination rates between these two methods.
The investigators hypothesize that SPA will result in less contamination of urine samples.
The investigators also hypothesize that there will be more success in obtaining an adequate urine sample (0.5 ml) by SPA, and that there will be no difference in associated complication rates between SPA and UC.
详细描述
See above and other sections.
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
- 72 Hours 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of contaminated urine samples per SPA and UC
时间窗: up to 2 years
For SPA samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or the growth of Candida species plus growth of any other microorganism. For UC samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or any growth \<10\^4 colony forming unit(CFU)/ml or the growth of Candida species plus growth of any other microorganism. The different cut-off used for contamination between UC and SPA samples stems from the fact that the UC procedure is not sterile in the neonatal population. Note that a bacterial load of \<10\^3 CFU/mL (e.g. 10\^1 or 10\^2 CFU/mL) does not grow in the media of either laboratory where our study samples are being cultured. Further sensitivity analyses will be performed on this outcome measure.
次要结局
- Success rates of obtaining urine by SPA versus UC(up to 2 years)
- Contamination rates of SPA versus UC (excluding clean catch urine)(up to 2 years)
- Number of attempts per procedure(up to 2 years)
- Time to perform the respective procedures(up to 2 years)
- Complication rates of SPA versus UC(up to 2 years)
研究者
Dr. Gregory Moore
Assistant Professor, Neonatologist
Children's Hospital of Eastern Ontario