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Ital J Pediatr ; 39: 63, 2013 Oct 07.
Article in English | MEDLINE | ID: mdl-24098953

ABSTRACT

AIM: To investigate the effectiveness of IgM-enriched immunoglobulins (IgM-eIVIG) in reducing short-term mortality of neonates with proven late-onset sepsis. METHODS: All 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. RESULTS: 79 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. CONCLUSION: This 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.


Subject(s)
Hospital Mortality , Immunoglobulin M/therapeutic use , Immunoglobulins, Intravenous/therapeutic use , Infant, Very Low Birth Weight , Sepsis/drug therapy , Sepsis/mortality , Adjuvants, Immunologic/therapeutic use , Analysis of Variance , Cohort Studies , Confidence Intervals , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Combinations , Female , Humans , Immunoglobulin A/therapeutic use , Immunoglobulin M/immunology , Infant, Newborn , Infusions, Intravenous , Intensive Care Units, Neonatal , Italy , Length of Stay , Male , Odds Ratio , Retrospective Studies , Risk Assessment , Sepsis/diagnosis , Severity of Illness Index , Survival Rate , Treatment Outcome
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