Standard versus hyperimmune intravenous immunoglobulin in preventing or treating neonatal bacterial infections.

Although current studies suggest that IVIg is safe, larger controlled trials will soon be published and will be important to confirm this observation. In addition, the current studies do not establish the efficacy of IVIg for either treating or preventing neonatal bacterial infections. Some studies with small numbers of infants suggest benefit of IVIg therapy and prophylaxis; however, the studies reviewed do not, individually or combined, prove efficacy. Clinicians and investigators must not confuse studies that prevent infection with those that treat infection because different therapeutic regimens may be necessary. Many questions remain concerning IVIg therapy, such as is IVIg efficacious in preventing or treating neonatal sepsis, what is the appropriate immunoglobulin dosage, and how variable is the pathogen-specific antibody activity of standard IVIg products. To determine the appropriate use of IVIg in neonates effectively, well-designed and carefully controlled trials are needed to address these issues using sufficiently large numbers of infants to arrive at valid scientific conclusions. Although many questions will be answered with the trials currently in progress, we must continue to base further recommendations for immunoglobulin therapy on solid scientific data.