CTRI/2017/04/008427
Not yet recruiting
未知
Pilot study to identify potential saliva-based biomarkers for diagnosis of neonatal sepsis.
Spot Healthcare Solutions Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Spot Healthcare Solutions Pvt Ltd
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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