Pilot study to identify potential saliva-based biomarkers for diagnosis of neonatal sepsis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Positive predictive value and negative predictive value of potential biomarkers for neonatal sepsis.
研究概览
简要总结
The objective of this study is to establish correlation between the elevated salivary levels of CRP, IL-6, IL-8 and IL-10 to the occurrence of neonatal sepsis. Also, the sensitivity, specificity, positive predictive value and negative predictive value of these test levels would be established after comparison of the results against blood culture result.
Available literature provides physiological levels for the said biomarkers in serum samples of neonates diagnosed with sepsis. However, no structured study has been done to identify these levels in salivary samples of the neonate. This study will aim at identifying the physiological levels and limit of detection of said salivary biomarkers to establish their usage in point-of-care diagnostics.Once the proposed tests are completed, we aim to incorporate the results to manufacture and distribute such a point-of-care diagnostic device for the public health system. Preterm and low birth weight babies often show only subtle and unspecific symptoms of sepsis. This leads to delay in diagnosis of late onset sepsis and can often be overlooked by mothers or volunteer health workers. The absence of well-equipped pathology labs and trained pathologists adds to the complication of diagnosing and treating sepsis within time. Many biomarkers that can be used as a good prognostic and diagnostic biomarker for systemic infections are found in the saliva. These include cytokines (TNF-alpha, IL-1, IL-2, IL-6, IL-8), multiple antimicrobial proteins, acute phase reactants and immunoglobins. We are conducting this study for detection of several salivary biomarkers which can be utilized for detection of sepsis in neonates.
Scope of the study: The scope of this study is limited to collection of saliva and blood samples from neonates suspected with sepsis (50 neonates) and a control group (50 neonates) to study the levels of CRP, IL-6 and IL-8 in saliva samples and comparing the results with the predictions of blood culture and sepsis screen.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
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
- •Serum samples showing positive results for sepsis screen and positive results for blood culture
- •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
- •Congenital malformation
- •Intraventricular bleed
- •Chronic lung disease
- •Perinatal asphyxia
- •Meconium aspiration syndrome
- •Chromosomal malformations.
结局指标
主要结局
Positive predictive value and negative predictive value of potential biomarkers for neonatal sepsis.
时间窗: August 2017
次要结局
- Biomarker detection based point-of-care test for neonatal sepsis screening.(December 2017)