Intravenous immunoglobulin for suspected or subsequently proven infection in neonates

Cochrane Database Syst Rev. 2010 Mar 17;(3):CD001239. doi: 10.1002/14651858.CD001239.pub3.


Background: Infections are important causes of neonatal morbidity and mortality. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis begins several months after birth. The administration of intravenous immunoglobulin (IVIG) may improve immune function by providing IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemo luminescence.

Objectives: To assess the effect of IVIG on mortality/morbidity caused by suspected infection in neonates and in those neonates who had suspected infection on study entry and later were confirmed as being infected.

Search strategy: We searched MEDLINE, EMBASE, The Cochrane Library, the reference lists of identified studies, meta-analyses and personal files in December 2009.

Selection criteria: We selected randomized or quasi-randomised controlled trials of IVIG for the treatment of suspected bacterial/fungal infection compared to placebo or no intervention in newborn infants (< 28 days old).

Data collection and analysis: Statistical analyses included Typical Relative Risk (RR), Risk Difference (RD), weighted mean difference (WMD), the number needed to treat to benefit (NNTB) (all with with 95% confidence intervals (CI) and the I(2) statistic to examine statistical heterogeneity.

Main results: The updated search identified one new study. Ten studies of variable quality undertaken in 8 countries are included in this review.Mortality in infants with clinically suspected infection was reduced following IVIG treatment [7 studies (n = 378); typical RR 0.58 (95% CI; 0.38, 0.89); typical RD -0.10 (95% CI; - 0.18, -0.03); NNTB 10 (95% CI; 6, 33); I(2) = 0%]. Mortality in cases of subsequently proven infection was reduced [seven trials (n = 262); typical RR 0.55 (95% CI; 0.31, 0.98);I(2) = 0%].

Authors' conclusions: Because of concerns about study quality, there is still insufficient evidence to support the routine administration of IVIG to prevent mortality in infants with suspected or subsequently proved neonatal infection. A large study of the effectiveness of IVIG in neonates with suspected infection has recently been completed. Results of the International Neonatal Immunotherapy Study (INIS trial), which enrolled 3,493 infants, are expected to be published in 2010 ( The results of that trial should establish the usefulness of IVIG for suspected infection in newborns.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Humans
  • Immunoglobulins, Intravenous / therapeutic use*
  • Immunologic Factors / therapeutic use*
  • Infant, Newborn
  • Infections / drug therapy*
  • Infections / mortality
  • Length of Stay
  • Randomized Controlled Trials as Topic
  • Sepsis / drug therapy*
  • Treatment Outcome


  • Immunoglobulins, Intravenous
  • Immunologic Factors