A clinical trial to study role of exchange transfusion in severe neonatal sepsis
Phase 2
Completed
- Conditions
- Health Condition 1: null- severe neonatal sepsis
- Registration Number
- CTRI/2012/09/003014
- Lead Sponsor
- Director PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
>1kg, neonates with severe sepsis
Exclusion Criteria
gasping/moribund/life threatening congenital malformation/ hypotensive shock requiring >2 inotropes/ significant non mucosal clinical bleed/ platelets <20000
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SurvivalTimepoint: 0-14 days from enrolment
- Secondary Outcome Measures
Name Time Method Change ion immunoglobulin(IgG,IgA,IgM), Complement(C3),ANC before and after interventionTimepoint: before and after intervention;Complications following exchange transfusionTimepoint: 0-2days;normalisation/persistence/worsening of organ dysfunctionTimepoint: 0-14 days from enrolment;survivalTimepoint: 0-6hrs from enrolment