跳至主要内容
临床试验/CTRI/2024/04/065471
CTRI/2024/04/065471尚未招募不适用

Estimate the time to blood culture positivity in neonates with sepsis a observational study

Indira gandhi institute of child health bengaluru1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月20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
150
试验地点
1
主要终点
The primary out come is to estimate the mean time to blood culture positivity in neonatal sepsis.

研究概览

简要总结

NEONATAL SEPSIS STANDS AS A SIGNIFICANT CONTRIBUTOR TO MORTALITY AND LONG TERM COMPLICATIONS IN BOTH DEVELOPED AND DEVELOPING COUNTRIES IT RANKS THE SECOND MAJOR CAUSE OF NEONATAL MORTALITY CLAIMING OVER A MILLION LIVES ANNUALLY ,WHILE CULTURE REMAINS THE GOLD STANDARD FOR DIAGNOSIS  ITS POSITIVITY RATES ARE NOTABLY LOW AND VARIABLE RANGING FROM 10 TO 15 % EARLY IDENTIFICATION OF INFECTING ORGANISM IN THE BLOOD IS CRUCIAL FOR OPTIMIZING ANTIBACTERIAL TREATMENT . TIME TO POSITIVITY PROVIDES INDIRECT INFORMATION ON THE BIOMASS REFLECTING THE BACTERAEMIA LOAD AND MICROBIAL GROWTH RATE A LOWER TIME TO POSITIVITY INDICATES A FASTER POSITVE SIGNAL SUGGEST A HIGHER INOCULUM IN THE BLOOD AND / OR A FASTER GROWTH RATE.

THE AIM OF  STUDY IS TO ESTIMATE THE IMPORTANCE OF TIME TO POSITIVITY AS A CRITICAL FACTOR INFLUENCING DECISION ABOUT ANTIBIOTIC TREATMENT AND ITS DURATION IN CHILDREN WITH SEPSIS

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Neonates less than 28 days.
  • Clinical sepsis.
  • Parents or guardians who has given voluntary signed written and informed consent.

排除标准

  • Presence of central line or PICC peripherally inserted central catheter line.
  • Major congenital malformation.

结局指标

主要结局

The primary out come is to estimate the mean time to blood culture positivity in neonatal sepsis.

时间窗: Any time before discharge

次要结局

  • Type of sepsis(Before Discharge)
  • Sepsis markers like CRP & Procalcitonin(Before Discharge)
  • Organism profile(Before Discharge)
  • Shock(Before Discharge)
  • Duration of hospital stay(Before Discharge)
  • Mortality(Before Discharge)

研究者

发起方
Indira gandhi institute of child health bengaluru
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Murali M

Indira Gandhi Institute of Child Health, Bengaluru

研究点 (1)

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