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临床试验/NCT01862822
NCT01862822已完成不适用

Position of Children During Urine Collection: Evaluation Study

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 803 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
803
试验地点
2
主要终点
Proportion of polybacterial urine analysis in each group

研究概览

简要总结

Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
2 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2 - 36 months
  • Non-toilet-trained children
  • Indication to bag urine collection with the following criteria :
  • fever ≥ 38.5 °C
  • unexplained fever
  • and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
  • age ≤ 12 months
  • fever ≥ 48 hours
  • poorly tolerated fever (chills ± cyanosis ± pronounced weakness...)
  • preceding episode of tract urine infection

排除标准

  • Parents opposed to the participation of their children in the study
  • Current antibiotic treatment or during the 8 preceding days of the urine collection
  • Genitals / perineal anomaly

研究组 & 干预措施

upright position

Experimental

Upright position during urine bag collection

干预措施: upright position (Other)

usual position

No Intervention

结局指标

主要结局

Proportion of polybacterial urine analysis in each group

时间窗: 1 hour

次要结局

  • The failure rate in upright position in private practice(1 hour.)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

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