Role of Prophylactic Intravenous Immunoglobulin Infusions in the Prevention of Neonatal Sepsis

Would the prophylactic administration of pooled human immunoglobulin help to preterm or low birth-weight infants help prevent systemic infection? A Cochrane Review has analysed 19 trials that randomised 5000 preterm or low birth weight infants to prophylactic intravenous immunoglobulin infusions or placebo (Ohlsson and Lacy, 2004b). Eight different IVIG preparations were used and there were 7 dosage variables. In 4 trials, infants received a single dose of intravenous immuno-globulin, and in the remaining 15 multiple doses were given. The meta-analysis of 10 of the trials comprising 3975 infants, showed a significant decrease in clinical and culture proven septic episodes in those infants who received immunoglobulin (p = 0.02). The prevention of 1 or more episodes of serious infection comprising sepsis, meningitis or urinary tract infection was studied in 16 studies comprising of 4986 infants and a combined analysis showed a significant decrease in serious infection in infants receiving immunoglobulin (p = 0.0005). Of 15 studies that reported on all cause mortality due to infection, intraventricular haemorrhage, necrotising enterocolitis or chronic lung disease, the combined analysis showed no significant decrease in mortality (4125 infants) and in ten studies of 1690 infants looking at prevention of infectious mortality, a combined analysis showed no significant decrease in mortality. Prophylactic intravenous immunoglobulin administration results in a 3% reduction in sepsis and 4% reduction in serious infection but no associated reduction in mortality or other co-morbidities.

Coagulase negative staphylococci are amongst the most common organisms causing infection in neonatal units (Urrea et al., 2003). Pooled polyclonal human immunoglobulin has high opsonic activity against group B streptococcus and pneu-mococcus but only low opsonic activity against coagulase negative Staphylococci, and opsonic activity varies between batches and preparations (Weisman et al., 1994; Fischer et al., 1994). Thus, routine use of commercially available pooled human immunoglobulin preparations is unlikely to significantly reduce the incidence of neonatal sepsis that is most commonly due to coagulase negative staphylococci, although it is likely to be most effective against organisms that are associated with more severe sepsis and mortality. The use of a preparation that is effective against coagulase negative staphylococci is more likely to reduce the overall incidence on sepsis, although it may have little effect on morbidity. BSYX-A110 is a monoclonal antibody that is protective for coagulase negative Staphylococci and Staphylococcus aureus, binding to a range of bacterial strains and is opsonic for most stains. A study involving adult healthy volunteers showed that it was safe and tolerable and antibody concentrations approached those levels that were protective in adults. Antibody concentrations were highly correlated to serum bacteriocidal activity. A randomised control trial looking at the effectiveness of BSYX-A110 to prevent episodes of neonatal sepsis is currently planned.

There is currently a multicentre randomised blinded placebo controlled trial looking at the effectiveness of pooled human immunoglobulin in the treatment of neonatal sepsis (international neonatal immunotherapy study - INIS) which has recruited 1839 babies at time of preparation of this manuscript

( Eligibility for the study requires an infant to be receiving antibiotics from proven or suspected infection and less than 1500 grams or ventilated or have evidence of infection in blood, CSF or another sterile site.

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