Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Occurence of infection
研究概览
简要总结
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.
In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.
Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Born between November 30, 2018 and December 31, 2022,
- •Gestational age below 33 weeks
排除标准
- •Severe malformation and / or disease requiring heavy surgical management in the neonatal period
- •Admitted at croix rousse hospital after the third day of life
结局指标
主要结局
Occurence of infection
时间窗: through study completion, an average of 60 days
Number of infections per 1000 catheter days, per patient during hospital stay
次要结局
未报告次要终点
