跳至主要内容
临床试验/CTRI/2025/07/091999
CTRI/2025/07/091999尚未招募不适用

Early removal and delayed removal of umbilical vein cathetar to prevent sepsis in low birth weight neonates: Randomised controlled trial

Dr Apeksha Rajeardad1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年8月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
124
试验地点
1
主要终点
1) To calculate the effects of both early and delayed umbilical vein cathetar removal in preventing sepsis in neonates with low birth weights

研究概览

简要总结

This study is a single centre, Parallel group , Randomised controlled trial which the effect of early and delayed removal of umbilical vein cathetar  on sepsis in low birth weight neonates will be compared. Patients will be recruited in two parallel groups and the effect of the dwell time of the cathetar on incidence of sepsis will be compared. This study would be helpfull so as to what should be the dwell time of the cathetar to prevent sepsis in low birth weight infants.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All low birth weight neonates admitted in NICU requiring atleast 5-7 days of central line.

排除标准

  • Neonates that flagged culture positive before catheterisation, neonates with fallen umbilical cord, Neonates with local site infection or other conditions like NEC,Peritonitis, Gastrochisis, Omphalocele, etc.

结局指标

主要结局

1) To calculate the effects of both early and delayed umbilical vein cathetar removal in preventing sepsis in neonates with low birth weights

时间窗: 2 years

次要结局

  • 1) To assess the evidence of localized infection in early versus delayed removal of umbilical vein catheter.(2 years)
  • To estimate the risk of development of Necrotising Colitis with various dwell times of umbilical vein cathetars.(2 years)
  • To assess the evidence of line blockage with various dwell times of umbilical vein cathetars.(2 years)
  • To measure time taken to achieve full feeds in various umbilical line dwell time settings.(2 years)

研究者

发起方
Dr Apeksha Rajeardad
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Apeksha Rajeardad

MGM Medical College and Hospital, Aurangabad

研究点 (1)

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