Intravenous immunoglobulin for suspected or proven infection in neonates.

  Updat­ed Cochrane review 27 March 2015


Neonates are at high­er risk of infec­tion due to immuno-incom­pe­tence. Mater­nal trans­port of immunoglob­u­lins to the fetus main­ly occurs after 32 weeks’ ges­ta­tion, and endoge­nous syn­the­sis begins sev­er­al months after birth. Admin­is­tra­tion of intra­venous immunoglob­u­lin (IVIG) pro­vides immunoglob­u­lin G (IgG) that can bind to cell sur­face recep­tors, pro­vide opson­ic activ­i­ty, acti­vate com­ple­ment, pro­mote anti­body-depen­dent cyto­tox­i­c­i­ty and improve neu­trophilic chemo-lumi­nes­cence. The­o­ret­i­cal­ly, infec­tious mor­bid­i­ty and mor­tal­i­ty could be reduced by the admin­is­tra­tion of IVIG.


To assess the effects of IVIG on mor­tal­i­ty and mor­bid­i­ty caused by sus­pect­ed or proven infec­tion at study entry in neonates. To assess in a sub­group analy­sis the effects of IgM-enriched IVIG on mor­tal­i­ty from sus­pect­ed infec­tion.

Authors’ con­clu­sions

The undis­putable results of the INIS tri­al, which enrolled 3493 infants, and our meta-analy­ses (n = 3973) showed no reduc­tion in mor­tal­i­ty dur­ing hos­pi­tal stay, or death or major dis­abil­i­ty at two years of age in infants with sus­pect­ed or proven infec­tion. Although based on a small sam­ple size (n = 266), this update pro­vides addi­tion­al evi­dence that IgM-enriched IVIG does not sig­nif­i­cant­ly reduce mor­tal­i­ty dur­ing hos­pi­tal stay in infants with sus­pect­ed infec­tion. Rou­tine admin­is­tra­tion of IVIG or IgM-enriched IVIG to pre­vent mor­tal­i­ty in infants with sus­pect­ed or proven neona­tal infec­tion is not rec­om­mend­ed. No fur­ther research is rec­om­mend­ed.