Clinical efficacy of IgM-enriched immunoglobulin as adjunctive therapy in neonatal and pediatric sepsis: a systematic review and meta-analysis

Ener Cagri Dinleyici, Georg Frey, Ermira Kola, Ulrike Wippermann, Artur Bauhofer, Alexander Staus, Peter Griffiths, Muhamad Azharry, Rinawati Rohsiswatmo

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1 Citation (Scopus)


Background: Sepsis is a major cause of mortality and morbidity globally, with around one-quarter of all sepsis-related deaths occurring in children under the age of 5. We conducted a meta-analysis and systematic review of the literature to evaluate the clinical effectiveness of an IgM-enriched immunoglobulin preparation in pediatrics patients and neonates with sepsis. Methods: Systematic searches of PubMed, the Cochrane Library and Embase databases were performed in November 2022, with no date limitations, to identify studies in which IgM-enriched immunoglobulin was used as adjunctive therapy in neonatal and pediatric patients with sepsis. Results: In total, 15 studies fulfilled the eligibility criteria, 13 neonatal studies and 2 pediatric studies. Pooled estimates from all studies indicated that mortality rates were significantly lower in patients who received treatment with the IgM-enriched immunoglobulin compared with controls (OR 0.41; 95% CI 0.32–0.55). Further analyses in neonatal studies, alone, showed a significant benefit with longer treatment durations (>3 days) vs. the recommended treatment duration (3 days) (OR 0.32; 95% CI 0.22–0.47) vs. (OR 0.61; 95% CI 0.41–0.92). Treatment with IgM-enriched immunoglobulin was associated with a lower mortality risk compared with controls in prospective studies vs. retrospective analyses (OR 0.37; 95% CI 0.27–0.51) vs. (OR 0.73; 95% CI 0.41–1.30). Conclusions: This systematic review suggests that adjunctive treatment with IgM-enriched immunoglobulin may reduce the risk of mortality in neonatal and pediatric populations. However, large randomized controlled trials are required to further substantiate and evaluate these findings.

Original languageEnglish
Article number1239014
JournalFrontiers in Pediatrics
Publication statusPublished - 2023


  • IgM-enriched immunoglobulin
  • infection
  • meta-analysis
  • mortality
  • neonate
  • pediatric
  • sepsis


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