Health Condition 1: null- neonates, showing clinical symptoms for sepsis
Conditions
Interventions
None listed
Sponsors
Spot Healthcare Solutions Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive predictive value and negative predictive value of potential biomarkers for neonatal sepsis.Timepoint: August 2017 | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker detection based point-of-care test for neonatal sepsis screening.Timepoint: December 2017 | — |
Countries
India
Contacts
Public ContactDr Kishore R Kumar
Kids Clinic India Pvt. Ltd (Cloudnine Hospital)
Outcome results
None listed