To check for neonatal infections using saliva
- Conditions
- Health Condition 1: null- neonates, showing clinical symptoms for sepsis
- Registration Number
- CTRI/2017/04/008427
- Lead Sponsor
- Spot Healthcare Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method