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临床试验/CTRI/2020/08/027195
CTRI/2020/08/027195尚未招募不适用

Lactate Clearance And Modified Sepsis Neonatal Score As Markers Of Adverse Outcomes In Neonates With Sepsis

SHUBHIKA GARG1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年8月25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
68
试验地点
1
主要终点
Mortality

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • 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].

排除标准

  • Neonates with Congenital abnormalities, Those who received blood transfusion or infusion Ringer’s lactate prior to examination, Neonates on 2nd line antibiotics, Asphyxiated neonates.

结局指标

主要结局

Mortality

时间窗: Recruitment | 6 hours | 28 days or earlier

次要结局

  • 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)

研究者

发起方
SHUBHIKA GARG
申办方类型
Private medical college

研究点 (1)

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