Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Relative risk of presenting a febrile UTI
研究概览
简要总结
Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed. At 24 months follow-up, an "impact on family scale" survey (IOFS) will be proposed parents.
详细描述
After diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. Circumcision will be performed at the time of valve resection. Children will undergo a cystogram between 1 and 4 months to control valve resection. They will be followed for two years and the number of febrile UTIs in each group will be compared. The diagnosis of febrile UTI will be confirmed by urethral catheterisation or suprapubic aspiration. A DMSA scan will be performed at the beginning and end of the study to determine whether children who have presented febrile UTIs show deterioration of their DMSA as compared to those who did not present febrile UTIs.
At 24 months follow-up, "impact on family scale" survey (IOFS) whose main objective is to evaluate the impact of family support for a child with posterior urethral valves will be proposed parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •aged 0 to 28 days
- •diagnosed with posterior urethral valves within the 28 first day of life
- •holders of parental authority affiliated to French national health insurance
- •informed consent signed by holders of parental authority
排除标准
- •boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
- •concomitant participation to another clinical trial
结局指标
主要结局
Relative risk of presenting a febrile UTI
时间窗: 24 months
次要结局
- number and type of adverse effects related to circumcision and antibiotic prophylaxis(24 months)
- Number of children with febrile UTIs in each group at two years(24 months)
- Evolution of the grade of reflux(At diagnosis and at 3 months)
- Comparison of the number of children who will show deterioration of their DMSA scan between children who have had UTIs and those who have not.(24 months)
- Evolution of compliance to antibioprophylaxis.(24 months)
- Identification of the responsible bacteria(24 months)