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临床试验/NCT05058534
NCT05058534已完成不适用

Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2018年11月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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