Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 主要终点
- catheter survival time
研究概览
简要总结
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates
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 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the neonatal intensive care unit (NICU) requiring central venous access.
- •Infants in whom either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) was inserted for clinical indications (Parenteral nutrition, administration of intravenous medications (e.g., antibiotics, inotropes, anticonvulsants, fluids) and blood sampling for frequent labs, especially in critically ill neonates).
- •Catheter insertion performed within the first 28 days of life.
排除标准
- •Neonates with major congenital anomalies (e.g.abdominal wall defects) that may interfere with catheter placement or outcomes.
- •Insertion site infection
- •Infants with severe coagulopathy or bleeding disorders contraindicating central catheter insertion.
- •Neonates who received both UVC and PICC simultaneously during the same admission.
- •Cases with incomplete clinical records or missing follow-up data.
结局指标
主要结局
catheter survival time
时间窗: From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)
Number of days each catheter remains functional and in use before removal
Central Line-Associated Bloodstream Infection (CLABSI) Incidence
时间窗: During the entire catheterization period (up to 28 days of life or until hospital discharge
Number of CLABSI events per 1,000 catheter-days, diagnosed according to CDC/NHSN criteria (positive blood culture + clinical signs of sepsis with no other source)
次要结局
未报告次要终点
研究者
Fatma Sayed Ahmed
Principal investigator
Assiut University