Lactate Clearance And Modified Sepsis Neonatal Score As Markers Of Adverse Outcomes In Neonates With Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
Neonatal sepsis is one of the major health problems in neonatal care. It has a high mortality rate of 18 per 1000 live births. To call a neonate in sepsis, a positive blood culture constitutes the gold standard. It is divided into 2 groups- Early onset sepsis(≤72hrs of life) and Late onset sepsis(>72hrs of life)
Blood lactate concentration is a marker of onset of tissue hypoxia, which is the risk factor for death in neonatal sepsis.
In practice there are various clinical scoring system for neonatal sepsis like CRIB(clinical risk index for baby score) II, SNAP(score for neonatal acute physiology)-II, SNAPPE(score for neonatal acute physiology-perinatal extension)-II, MSNS(modified sepsis neonatal score) for prediction of prognosis. In this study we are using MSNS score.
So we will take both these parameters to assess To study number of newborn deaths occurring in infants with lactate clearance <10% and Modified Sepsis Neonatal Score≤10 till 28days or earlier.
Neonates upto 7days will be taken in for study who fulfill the inclusion criteria and outcome evaluation is done at recruitment and 6hours later of first starting the treatment
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Day(s) to 7.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Neonates with a clinical diagnosis of sepsis, who are blood culture positive or Neonates with clinical diagnosis of sepsis with 2 or more of the following positive lab criteria [TLC<5000/mm3, low absolute neutrophil count, immature to total neutrophil ratio>0.2, CRP-positive].
Exclusion Criteria
- •Neonates with Congenital abnormalities, Those who received blood transfusion or infusion Ringer’s lactate prior to examination, Neonates on 2nd line antibiotics, Asphyxiated neonates.
Outcomes
Primary Outcomes
Mortality
Time Frame: Recruitment | 6 hours | 28 days or earlier
Secondary Outcomes
- To study complications of neonatal sepsis that might develop in infants with lactate clearance 10% and Modified Sepsis Neonatal Score≤10 who survive till 28days or earlier.(Recruitment, 6hours, 28days or earlier)