Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
研究概览
简要总结
The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.
Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection.
They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last.
A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s.
No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking.
We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required.
详细描述
The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.
Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection.
They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last.
A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s.
No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants under the age of 2 years and who have not acquired walking
- •To which the investigating doctor asked the indication of a urine sample in search of a urinary tract infection, ionic and metabolic disorder
- •Do not exhibiting signs of vital distress (respiratory or circulatory or neurological)
- •To which the bladder stimulation does not delay the treatment
- •Obtaining the authorization of the holders of parental authority
- •Affiliation to social security
- •Clinical examination
排除标准
- •Parental Refusal
- •Infants> 2 years or who has walking
- •Infant occurring outside the pediatric emergency timetables of care permanently
- •Infant having vital signs of distress (respiratory and / or circulatory and / or neurological)
- •Infant for which the bladder stimulation could delay the management
研究组 & 干预措施
bladder stimulation
Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes.
干预措施: Bladder stimulation (Other)
结局指标
主要结局
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
时间窗: During baseline at time 0
• Obtaining urine or not (YES / NO) by bladder stimulation in less than 3 minutes (max 2 attempts). This is evaluated by an investigator who directs the bladder stimulation technique.
次要结局
- alternative of the urine sample(During baseline after 2 attemps of bladder stimulation)
- Evaluation of the tolerance of the infant(During baseline at time 0)
- evaluation period of urine collection(During baseline at time 0)