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
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