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临床试验/EUCTR2015-000874-36-GB
EUCTR2015-000874-36-GB进行中(未招募)1 期

The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study - Antiseptic Randomised Controlled Trial for Insertion of Catheters v1.0

orfolk and Norwich University Hospitals NHS Trust0 个研究点目标入组 116 人开始时间: 2015年9月10日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
116

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Preterm infants born at <34 weeks' gestation
  • Requiring routine insertion of a PCVC for parenteral nutrition
  • No new suspected sepsis with commencement of antibiotics occurring within the 48 hours preceding planned catheter insertion
  • No other indwelling PCVC already in situ
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 93
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • No realistic prospect of survival in the short term
  • Life-threatening congenital abnormality
  • Already has another indwelling PCVC in situ or was previously enrolled into the study in respect of an earlier PCVC episode
  • Positive blood culture within the past 7 days without a subsequent negative BC result
  • Antibiotic treatment commenced for suspected sepsis within the preceding 48 hours

研究者

发起方
orfolk and Norwich University Hospitals NHS Trust

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