Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 736
- 试验地点
- 2
- 主要终点
- Frequency of patients with at least one inflammatory episode sepsis-like.
研究概览
简要总结
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU).
In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated.
In-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.
详细描述
BACKGROUND Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU).
This particulate consists of metals, drug crystals, glass fragments or cotton fibres and can be generated by drug packaging, incomplete reconstitution and chemical incompatibilities.
Filters have been shown to remove micro-organisms, endotoxin, air and particles in critically-ill adults and older infants, but its benefits in newborn remain to be demonstrated.
Although recommendations for the use of in-line intravenous filters have been published, there is no consensus on their use.
Moreover, 50% of inflammatory episodes in the setting of NICU are blood culture-negative. These episodes could be partly related to the presence of particles in the infusion lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to NICU with at least one central venous catheter
排除标准
- •Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment
结局指标
主要结局
Frequency of patients with at least one inflammatory episode sepsis-like.
时间窗: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months
Frequency of patients with at least one inflammatory episode sepsis-like, defined by alteration of the biomarkers of inflammation in a negative-culture contest.
次要结局
- Frequency of patients with at least one episode of sepsis.(From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months)
研究者
Francesco Cresi, MD, PhD
Study Director
University of Turin, Italy