To study the role of giving intravenous immunoglobulin injection for treatment of septicemia in newborn babies.
Phase 4
- Conditions
- Health Condition 1: R652- Severe sepsis
- Registration Number
- CTRI/2020/08/027019
- Lead Sponsor
- MLN Medical College Prayagraj Uttar Pradesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Neonates with clinical signs of sepsis and positive sepsis screen.
2.Neonates with positive blood culture.
3.Neonates with septic meningitis diagnosed on basis of biochemical and microbiological examination or CSF culture.
Exclusion Criteria
1.All neonates whose attendants did not give consent for IVIG administration.
2.All neonates whose attendants who did not give consent to involve in Study.
3.All neonates with major congenital malformation.
4.All neonates with known metabolic disease.
5.Neonates in shock or require positive pressure ventilation at the time of admission.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of days of admission in hospitalTimepoint: 7 days and 30 days
- Secondary Outcome Measures
Name Time Method Mortality rate. <br/ ><br>Weight gain during hospital course <br/ ><br>Need for ventilation. <br/ ><br>Number of days of Oxygen requirement. <br/ ><br>Development of necrotizing enterocolitis. <br/ ><br>Side effects of IvIg. <br/ ><br> <br/ ><br>Timepoint: 1day and 30 days