Are IgM-enriched immunoglobulins an effective adjuvant in septic VLBW infants?

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.

A Systematic Review

“…It has been used internationally in countries including: United States of America (USA), 15–19 Canada, 20–32 Spain, 33–35 Italy, 36,37 Brazil, 12,38 India, 39,40 France, 41 Thailand, 42 Netherlands, 43 Ireland, 44 China, 45 and Iran 46 . Two studies had cohorts that were derived from populations across two countries including the USA and Canada.…”

“…Samples ranged from the smallest sample of 32 28 to the largest cohort of 25,429. 6 Nine studies included sample sizes less than 100 15,28,33,34,36,39,42–44 ; however there were eight larger studies with sample sizes over 1,000 6,16,17,27,30–32,47 . Newborns in the studies varied greatly across gestational age and birth weight.…”

“…Some studies specifically focused on very low birth weight newborns 19,44,48 and extremely low gestational age newborns 16,17 which are premature populations with expected risk of illness severity. Not only was the SNAP-II used across all gestational ages and birth weights, it was also used across many specific morbidities including: congenital diaphragmatic hernia, 15,21,24,25,28,29 chorioamnionitis, 27,48 sepsis, 33–36,39 gastroschisis, 20,26 patent ductus arteriosus, 19,22 persistent pulmonary hypertension, 42 and respiratory distress. 45 …”

“…24 This seems to indicate that perhaps the quality of care in referral centers is not as optimal as within a tertiary center that routinely cares for the most critically ill infants. Capasso et al 36 focused on outcomes of septic newborns who did and did not receive immunoglobulin along with antibiotic therapy. The SNAP-II was used to demonstrate that the groups were homogeneous for severity of illness prior to comparison of the outcomes with varying treatments.…”

Impacto De La Pasteurización/Liofilización en El Contenido Disponible De Inmunoglobulinas en Leche Humana Madura. Estudio De Aplicación en Bancos De Leche Humana en Hospitales

“…Específicamente, para IgM en la pasteurización a 62,5 °C durante 30 minutos se reporta pérdida significativa con respecto a la concentración inicial (16,(22)(23)(24). La importancia de la IgM radica en que, en respuesta a un estímulo antigénico, rápidamente incrementa su concentración y se caracteriza por poseer capacidad neutralizante, precipitante y aglutinante (25).…”