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Sepsis is an important, but sometimes undiagnosed, cause of perinatal brain damage and mortality. In term infants, blood concentrations of inflammatory cytokines are elevated in those later diagnosed with cerebral palsy. In preterm infants, infection remote from the brain may predispose to cerebral white matter damage. While effective antibiotic treatment is essential, resistance to antibiotics is increasing. Adjuvant therapies, such as intravenous immunoglobulin (IVIG), therefore offer an important additional strategy. Three recent Cochrane systematic reviews of randomised controlled trials in nearly 6,000 patients suggest that non-specific, polyclonal IVIG is safe, reduces sepsis by 3-4% in prophylaxis and may reduce mortality by 50% in treatment of neonatal sepsis. However, the trials of treatment were small and lacked follow up data. This protocol is for a large, simple, international trial, to assess reliably whether treatment of neonatal sepsis with IVIG reduces mortality and adverse neuro-developmental outcome. It needs no special expertise and can be conducted simultaneously with other studies.
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