Antistaphylococcal immunoglobulins to prevent staphylococcal infection in very low birth weight infants.

BACKGROUND: Nosocomial infection is a major problem affecting the immediate health and long-term outcome of preterm and very low birth weight neonates. More than half of these infections are caused by staphylococci. Various type specific antibodies targeted at different antigenic markers of Staphylococcus have been developed and have shown promise in animal studies.
OBJECTIVES: To evaluate the efficacy and safety of antistaphylococcal immunoglobulins in the prevention of Staphylococcal infection in very low birth weight infants. SEARCH STRATEGY: Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials (The Cochrane Library) were searched from their inception until February 2009. In addition, abstracts of major pediatric meetings of last seven years were searched. SELECTION CRITERIA: Randomized and quasi-randomized studies of antistaphylococcal immunoglobulins for the prevention of staphylococcal infections in preterm or very low birth weight neonates were reviewed by both authors for their eligibility for inclusion. Studies of any dose and/or route were included. Quality of studies was evaluated using criteria of masking of randomization, masking of intervention, completeness of follow-up and masking of outcome assessment by both review authors. DATA COLLECTION AND ANALYSIS: Data from the primary author were obtained where published data provided inadequate information for the review or where relevant data could not be abstracted. Data were abstracted independently by both review authors. Statistical methods included calculation of relative risk (RR), risk difference (RD), number needed to treat (NNT) and weighted mean difference (WMD) when appropriate. Ninety five percent confidence intervals (CI) was used for these estimates of treatment effects. A fixed effect model was used for meta-analyses. MAIN
RESULTS: Three eligible studies were included (two studies of INH A-21 and one study of Altastaph involving a total of 2,701 neonates). Three reports of Pagibaximab were published as abstracts and will be considered for inclusion when further information is obtained. There were no significant differences noted in the risk of Staphylococcal infection between INH A-21 vs. placebo (typical RR 1.07, 95% CI 0.94, 1.22) or Altastaph vs. placebo (RR 0.86, 95% CI 0.32, 2.28); the risk of other bacterial infection between INH A-21 vs. placebo (typical RR 0.87, 95% CI 0.72, 1.06) or Altastaph vs. placebo (RR 0.93, 95% CI 0.53, 1.64); or the risk of any infection between INH A-21 vs. placebo (RR 1.00, 95% CI 0.91, 1.09) or Altastaph vs. placebo (RR 0.93, 95% CI 0.54, 1.62). There was no significant difference in the incidence of relevant secondary outcomes (chronic lung disease at 28 days, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity or duration of antibiotic and vancomycin use). AUTHORS'
CONCLUSIONS: Antistaphylococcal immunoglobulins (INH A-21 and Altastaph) are not recommended for prevention of staphylococcal infections in preterm or VLBW neonates. Further research to investigate the efficacy of other products such as Pagibaximab is needed.