Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
研究概览
简要总结
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.
详细描述
UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All term and preterm newborns requiring UVC insertion will be included in the study.
排除标准
- •All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.
结局指标
主要结局
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
时间窗: 14 days
Using the chest and abdominal X-ray, the distance of the UVC tip position in reference to the diaphragm level is measured.UVC tip position is then labeled as either IDEAL,SHORT or DEEP position. Ideal position is defined as the UVC tip is at the diaphragm level or +/- 0.5cm distance from the diaphragm. Short UVC is defined if the UVC tip is \>0.5 cm below the diaphragm.Deep UVC position is defined as if the UVC tip is \> 0.5cm above the diaphragm.
次要结局
- Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study(14 days)