Abstract
AimTo investigate the effectiveness of IgM-enriched immunoglobulins (IgM-eIVIG) in reducing short-term mortality of neonates with proven late-onset sepsis.MethodsAll VLBW infants from January 2008 to December 2012 with positive blood culture beyond 72 hours of life were enrolled in a retrospective cohort study. Newborns born after June 2010 were treated with IgM-eIVIG, 250 mg/kg/day iv for three days in addition to standard antibiotic regimen and compared to an historical cohort born before June 2010, receiving antimicrobial regimen alone. Short-term mortality (i.e. death within 7 and 21 days from treatment) was the primary outcome. Secondary outcomes were: total mortality, intraventricular hemorrhage, necrotizing enterocolitis, periventricular leukomalacia, bronchopulmonary dysplasia at discharge.Results79 neonates (40 cases) were enrolled. No difference in birth weight, gestational age or SNAP II score (disease severity score) were found. Significantly reduced short-term mortality was found in treated infants (22% vs 46%; p = 0.005) considering all microbial aetiologies and the subgroup affected by Candida spp. Secondary outcomes were not different between groups.ConclusionThis hypothesis-generator study shows that IgM-eIVIG is an effective adjuvant therapy in VLBW infants with proven sepsis. Randomized controlled trials are warranted to confirm this pilot observation.
Highlights
An immature innate immune response is a major factor in the high rate of systemic infections among very low birth weight newborns
Inclusion criterium was the diagnosis of blood culture-proven late onset sepsis in VLBW infants
Of the 82 VLBW infants enrolled, 2 neonates were excluded for congenital anomalies and one for TORCH infection; of the remaining 79, 40 patients received antibiotics in association to IgM-eIVIG and 39 received antibiotic treatment alone
Summary
An immature innate immune response is a major factor in the high rate of systemic infections among very low birth weight newborns. A recent international, randomised trial, INIS study, on standard immunoglobulins (S-IVIG) added to antibiotic therapy in neonates with suspected infection concluded that S-IVIG had no effect on death or major disability at the age of 2 years [5]. The results of INIS study constitute the database of a recent Cochrane review on the use of Ig for sepsis in neonate [6]. There are limited data on passive immunotherapy with IgM-eIVIG in septic neonates and no specific report is focused on VLBW babies though they have the highest risk of invasive infection. We have conducted a retrospective, cohort study on the use of IgM-eIVIG in addition to antibiotic therapy in VLBW neonates with late onset sepsis as an hypothesis generator for future prospective clinical trials
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