跳至主要内容
临床试验/NCT03578978
NCT03578978Unknown不适用

A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital

Clinical Research Centre, Malaysia2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Diagnostic utilities of biomarkers of interest in diagnosing LONS

研究概览

简要总结

This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal sepsis (LONS) and/or necrotizing enterocolitis (NEC). Neonates who meet the initial screening criteria for suspected LONS or NEC will be recruited into the study. A group of 50 neonates who are clinically well, admitted to the nursery or general ward for reasons other than neonatal sepsis or NEC will also be recruited into the study.

详细描述

The diagnosis of neonatal sepsis is challenging especially the very low birth weight infants as the signs and symptoms of sepsis are nonspecific and can be attributed to non-infected aetiologies including exacerbation of bronchopulmonary dysplasia, apnoea of prematurity and gastroesophageal reflux. Blood culture remains the gold standard for diagnosing septicaemia (either bacteremia or fungemia). However, its effectiveness in the population of preterm infants is compromised.Given the dire consequences of not treating the sepsis early, clinicians tend to have a low threshold for treatment. This leads to overuse of antimicrobials, promotion of antimicrobial resistance, exposure of infants to avoidable side effects from the antimicrobial treatment, prolonged hospitalisation and increased healthcare costs. Hence, there is a need for a clearly defined algorithm for diagnosing LONS and NEC. This study aims to examine the diagnostic utilities of a panel of sepsis biomarkers and explore if they can be incorporated into a diagnostic algorithm which hopefully, can be translated into clinical practice in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
72 Hours 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with signs and symptoms suggestive of sepsis and/or NEC and requiring full sepsis screening and start of intravenous antibiotic(s), or a change of antibiotics (if already on)
  • Infants with postnatal age greater than 72 hours and less than 28 days of life, of all gestation
  • Parents of potential neonates who are willing to give written informed consent
  • Healthy subjects
  • Inclusion Criteria:
  • Clinically well infants admitted to Sibu Hospital for reasons other than neonatal sepsis or NEC
  • Infants with postnatal age greater than 72 hours and less than 28 days of life, of all gestation

排除标准

  • Infants who have lethal or life-threatening congenital abnormalities
  • Infants who have chromosomal abnormalities
  • Infants who have hypoxic ischemic encephalopathy
  • Infants who are on steroid treatment
  • Infants who received blood transfusions
  • Post-operative infants

结局指标

主要结局

Diagnostic utilities of biomarkers of interest in diagnosing LONS

时间窗: Hour 0 to 72

Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS

Diagnostic utilities of biomarkers of interest in diagnosing NEC

时间窗: Hour 0 to 72

Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS

次要结局

未报告次要终点

研究者

发起方
Clinical Research Centre, Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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