Evaluation of Feasibility of Urine Collection Using Perineal Bag Versus Bladder Stimulation in Infants Less Than 12 Months Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- Urine sample collection
研究概览
简要总结
Randomize trial by including patients up to 12 months old in whom a urine sample by a non-sterile method was requested under physician criteria. Intention-to-treat analysis was made.
Urine dipstick was considered as altered if it was positive in leukoesterase test (≥2+) or nitrite test. In patients with an altered urine dipstick, a sterile sample was obtained for culture. If there was an initial altered urine dipstick with a subsequent negative urine culture it was considered as contaminated urine.
详细描述
Randomised not-blind trial developed between june 1st, 2013 and December 31st, 2014 at the Pediatric Emergency Department (PED) of Rio Hortega Universitary Hospital, a secondary hospital located in Valladolid (Spain).
Participants were infants up to one-year-old in whom a urine sample by a non-sterile method was requested under physician criteria and a written consent was signed by parents/caregivers.
The study obtained the approval of Western Valladolid Review Board.
Exclusion criteria:
Patients were excluded from the study if they met at least one of the following criteria: a) patients in whom a urine sample obtained by sterile method was needed by protocol (i.e. febrile infants less than 3 months old), b) patients with underlying disease unable to oral intake of liquids, c) patients whom parents/caregivers refused to sign the informed consent.
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 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants up to one-year-old in whom a urine sample by a non-sterile method was requested under physician criteria and a written consent was signed by parents/caregivers.
排除标准
- •patients in whom a urine sample obtained by sterile method was needed by protocol (i.e. febrile infants less than 3 months old)
- •patients with underlying disease unable to oral intake of liquids
- •patients whom parents/caregivers refused to sign the informed consent.
结局指标
主要结局
Urine sample collection
时间窗: 5400 seconds
Primary outcome is the obtention of an urine sample within the time determinate for each technique. Bladder stimulation technique is a procedure that lasts 5 minutes (300 seconds). If urine sample was obtained of patients that underwent this technique, it was considered a success. if not, a failure. The same was determined for the perineal bag group. In this case, our hospital's protocol recommends to use a perineal bag no longer than 30 minutes, due to risk of contamination, and after three attempts, to consider other options, so in the patients that a perineal bag was placed, if obtaining a urine sample within 90 min (5400 seconds) was considered a success. Otherwise, it was considered as a failure. For the purpose of the primary objective of the study, rate of falilures of each technique was compared.
次要结局
未报告次要终点
研究者
ROBERTO VELASCO
MD PhD
Hospital del Río Hortega