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临床试验/NCT00516360
NCT00516360Unknown4 期

Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates

National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
4 期
入组人数
150
试验地点
2
主要终点
Catheter tip microbial colonization

研究概览

简要总结

The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.

详细描述

Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. This study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. This study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site.

This study will last 1 year. There are no study visits. The placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. Participants will be randomly assigned to one of two groups. Catheters of Group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.

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
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Admitted to the NICU
  • Umbilical vein catheter or peripherally inserted central venous catheter (PICC) anticipated to be in place for more than 48 hours
  • Parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change

排除标准

  • Known CRBSI-positive blood culture at the time of catheter line placement.
  • Not expected to survive for more than 48 hours
  • Broviac or any other surgically-placed central catheters
  • Any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant

结局指标

主要结局

Catheter tip microbial colonization

时间窗: at the time of catheter removal

次要结局

  • Time to hub microbial colonization(at the time of catheter removal)
  • Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin(at the time of catheter removal)

研究者

研究点 (2)

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