Rachitis Device Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents
研究概览
简要总结
On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns
Objective of the study:
Clinical feasibility of the urine collection device, indicated by staff and parents.
Study design:
The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed.
Study population:
Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents
排除标准
- •No informed consent
- •Defective skin in genital region
- •Three previous tests in the same subject
结局指标
主要结局
Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents
时间窗: 1 day
With concern to feasibility we want to know whether this device is able: * easy to apply to the neonate * to only collect urine * to exclude stool admixture * easy to use by the nurses * comfortable for te neonates
次要结局
- Skin reactions(1 week)
- Skin irritability(1 week)