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

Department of Pediatrics, Eskisehir Osmangazi University Faculty of Medicine, Eskisehir, Türkiye. Klinik für Neonatologie, Darmstädter Kinderkliniken Prinzessin Margaret, Perinatalzentrum Südhessen, Darmstadt, Germany. Pediatric Intensive Care Unit, University Hospital Center "Mother Teresa", Tirana, Albania. Corporate Medical Affairs, Biotest AG, Dreieich, Germany. Corporate Clinical Research & Development, Biotest AG, Dreieich, Germany. Medical and Scientific Affairs, Biotest UK, Birmingham, United Kingdom. Department of Child Health, Neonatology Division, Dr. Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia.

Frontiers in pediatrics. 2023;11:1239014
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Abstract
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.
Study details
Study Design : Systematic Review
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine