ACTRN12606000273583
Completed
Phase 3
Randomised controlled trial of intravenous immunoglobulin of neonates with sepsis using intravenous immunoglobulin (Intragam P) and being treated with antibiotics. Primary outcomes are mortality and morbidity.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infants with sepsis. Infants being treated with antibiotics are eligible. Infants can be preterm or term.
- Sponsor
- The University of Sydney
- Enrollment
- 5000
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants are eligible if: they are receiving antibiotics with clinical evidence of definite or highly probable sepsis, there is substantial uncertainty that IVIG is indicated, birth weight is less than 1500g OR already has positive blood or cerebro spinal fluid culture OR receiving artifical ventilation.
Exclusion Criteria
- •IVIG already given or thought to be needed or contra\-indicated.
Outcomes
Primary Outcomes
Not specified
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