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临床试验/CTRI/2017/04/008427
CTRI/2017/04/008427尚未招募未知

Pilot study to identify potential saliva-based biomarkers for diagnosis of neonatal sepsis.

Spot Healthcare Solutions Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • The inclusion criteria will include all neonate who show clinical symptoms for sepsis (i.e any two of the following symptoms: respiratory distress, temperature fluctuation, diarrhea, reduced movements, reduced sucking, seizures, bradycardia, swollen belly area, heart rate >160). A hematological sepsis screen (as per section 8.4.2) and blood culture will be conducted.
  • The obtained sample groups will be categorized in following sections
  • 1. Serum samples showing positive results for sepsis screen and positive results for blood culture
  • 2. Serum samples showing positive results for sepsis screen but negative results for blood culture
  • Diagnosis of sepsis will be confirmed for neonates showing positive result for sepsis screen and a positive result for blood culture.
  • CONTROL GROUP: 50 age and sex matched healthy neonates (showing no clinical symptom for sepsis) will be recruited as the control group for this study.

排除标准

  • Neonates who exhibit clinical symptoms for or have been identified with the following will be excluded from this study
  • 1. Congenital malformation
  • 2. Intraventricular bleed
  • 3. Chronic lung disease
  • 4. Perinatal asphyxia
  • 5. Meconium aspiration syndrome
  • 6. Chromosomal malformations

研究者

发起方
Spot Healthcare Solutions Pvt Ltd

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