Estimate the time to blood culture positivity in neonates with sepsis a observational study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- The primary out come is to estimate the mean time to blood culture positivity in neonatal sepsis.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Neonates less than 28 days.
- •Clinical sepsis.
- •Parents or guardians who has given voluntary signed written and informed consent.
Exclusion Criteria
- •Presence of central line or PICC peripherally inserted central catheter line.
- •Major congenital malformation.
Outcomes
Primary Outcomes
The primary out come is to estimate the mean time to blood culture positivity in neonatal sepsis.
Time Frame: Any time before discharge
Secondary Outcomes
- 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)
Investigators
Dr Murali M
Indira Gandhi Institute of Child Health, Bengaluru