Italian journal of pediatrics · 2013
Are IgM-enriched immunoglobulins an effective adjuvant in septic VLBW infants?
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Capasso Letizia, Borrelli Angela Carla, Parrella Claudia, Lama Silvia, Ferrara Teresa, Coppola Clara, Catania Maria Rosaria, Iula Vita Dora, Raimondi Francesco
Аннотация
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.
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.
Предметные рубрики MeSH
Adjuvants, ImmunologicAnalysis of VarianceCohort StudiesConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug CombinationsFemaleHospital MortalityHumansImmunoglobulin AImmunoglobulin MImmunoglobulins, IntravenousInfant, NewbornInfant, Very Low Birth WeightInfusions, IntravenousIntensive Care Units, NeonatalItalyLength of StayMaleOdds RatioRetrospective StudiesRisk AssessmentSepsisSeverity of Illness IndexSurvival RateTreatment Outcome