IgM and IgA enriched polyclonal immunoglobulins reduce short term mortality in extremely low birth weight infants (ELBW) with sepsis: a retrospective cohort study.

BACKGROUND Immunoglobulin supplementation is a debated strategy in fighting sepsis. We evaluated a polyclonal IgM and IgA enriched immunoglobulin (IgMeIVIG) preparation in reducing the short term mortality in extremely low birth weight neonates (ELBW) with proven infection. METHODS ELBW infants born from January 2008 to December 2014 were eligible for this retrospective casecontrol analysis if they were symptomatic and had a positive blood culture after 72hours of life. Patients received antibiotic treatment with or without IgMeIVIG (intravenously,250mg/kg/day for 3 days) within the 24 hours from clinical suspicion as per indication of the attending physician. Shortterm (7 and 21 days) mortality was the study primary outcome while secondary outcomes were: mortality at discharge, intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leukomalacia, and retinopathy of prematurity. RESULTS Each group was composed by thirtynine infants. Both groups were similar for antenatal steroids, mode of delivery, birth weight, gestational age and SNAPII score as indicator of disease severity. Infants receiving IgMeIVIG had a significantly lower shortterm mortality compared with neonates receiving antibiotics alone: 6/39 (15%) vs 14/39 (36%); p = 0.038. No differences in other outcomes were found. CONCLUSIONS This study shows that IgMeIVIG may have a role as adjuvant therapy in ELBW infants with proven sepsis. We warrant future prospective, blinded RCT studies where IgMeIVIG can be consistently used if needed throughout the NICU admission in ELBW septic neonates to appropriately evaluate its effect on mortality at discharge.