Adjuvant use of intravenous immunoglobulin in the treatment of neonatal sepsis: a systematic review with a meta-analysis

Neonatal sepsis remains the major cause of mortality and morbidity including neurodevelopmental impairment and prolonged hospital stay in newborn infants. Despite of advances in technology and optimal antibiotic treatment, incidence of neonatal sepsis and its complications remains unacceptably high especially in developing countries. Premature neonates in particular are at higher risk due to developmentally immature host defense mechanisms. Though not approved by Food and Drug Administration (FDA) U.S.A, off label use of intravenous immunoglobulin continues in many countries. Recent evidences showed no significant decrease in the mortality rate or other outcomes when intravenous immunoglobulin is administered in addition to standard therapies. Hence, use of intravenous immunoglobulin in suspected or proven neonatal sepsis is not recommended. The expense of prophylactic use of intravenous immunoglobulin administration for both term and preterm newborn population, given the minimal benefit is not justified. Future studies are required which should focus on other prophylactic or adjuvant treatment modalities in addition to the standard therapy in neonatal sepsis.

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“…The global effect of this outcome showed no statistically signifi cant difference between the groups 28 .…”

Section: Latest Clinical Evidencementioning

confidence: 74%

Intravenous Immunoglobulin in Neonatal Sepsis

Jiang

Gautam

2013

J. Nepal Paedtr. Soc.

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“…In Franco’s meta-analysis, the mortality rate was evaluated for 7 RCTs including 3,756 patients. The global effect of intravenous immunoglobulin vs placebo treatment on mortality was not significantly different [20]. In the present study, we included 14 studies on the use of intravenous immunoglobulin; however, the updated studies exhibited similar results.…”

Section: Discussionmentioning

confidence: 98%

“…The results of previous systematic reviews and meta-analyses indicated that intravenous immunoglobulin therapies had a positive effect on reducing mortality from neonatal sepsis [19]. Another recent meta-analysis that included more trials demonstrated that intravenous immunoglobulin therapies showed no benefit regarding mortality among neonates with sepsis [20]. These studies were conventional meta-analyses that did not investigate the efficacies of different types of immunotherapies in neonates with sepsis.…”

Section: Introductionmentioning

confidence: 99%

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis

Yang

Wang

et al. 2019

BMC Pediatr

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Background To investigate the efficacies of different immunotherapies in neonates with suspected or proven sepsis. Methods We searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2019 that investigated different immunotherapies in neonates with suspected or proven sepsis. Comparisons were among immunotherapies and between immunotherapy and placebo. The review was registered in the PROSPERO CRD database. Results All-cause mortality was not significantly different between patients who received the immunoglobulin (IgG), IgM-enriched immunoglobulin (IgGAM), granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) immunotherapies and those who received placebo. The RRs of the immunotherapies were 0.80 (95% CI: 0.57 to 1.1), 0.45 (95% CI: 0.17 to 1.0), 0.93 (95% CI: 0.64 to 1.2) and 0.67 (95% CI: 0.39 to 1.1), respectively. Compared with placebo, none of the interventions showed statistically significant differences in the duration of hospital stay. The MDs of the immunotherapies were − 2.7 (95% CI: − 8.4 to 3.5), − 0.18 (95% CI: − 7.3 to 7.7), − 1.7 (95% CI: − 7.3 to 3.9) and − 7.2 (95% CI: − 28 to 13), respectively. Conclusions No significant differences in all-cause mortality or the duration of hospital stay were found in neonates with suspected or proven sepsis treated with the four types of immunotherapies and those treated with placebo. Electronic supplementary material The online version of this article (10.1186/s12887-019-1609-1) contains supplementary material, which is available to authorized users.

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“…On the other hand, the role of intravenous immunoglobulin (IVIG) as an adjunctive treatment in sepsis has been shown in experimental and clinical trials due to its positive effects on the infant's immune system (13)(14)(15). The pathophysiological causes for administration of IVIG composed of complement activation, neutralization of endotoxin and a wide variety of super-antigens, enhancement of opsonization and phagocytosis, and modification of endotoxin-released cytokines or mononuclear blood cells.…”

Section: Introductionmentioning

confidence: 99%

Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis: A Clinical Trial Study

Goodarzi¹,

Dustkhah²,

Khamesan³

et al. 2017

Acta Healthmedica

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Background:The incidence of severe sepsis and septic shock is higher among preterm infants. Prevention of neonatal sepsis has remained a global challenge in recent decades. The role of intravenous immunoglobulin (IVIG) as an adjunctive treatment in sepsis has been shown in experimental and clinical trials. Objective: The present controlled clinical trial was carried out with the objective of determining the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis. Methods: This single-blind randomized clinical trial was performed in Hormozgan in Iran in 2015. Preterm neonates with low birth weight (LBW) were recruited in the study and were randomly divided into two groups. The intervention group received IVIG in addition to routine and general care, including antibiotic treatment, while the control group was given routine and general care without IVIG. IVIG was given to members of the intervention group at slow intravenous infusions at a dose of 500 mg/kg within 12 h and 3 days of birth, respectively. At the end of first week, two groups were compared for mortality rate, total number of days of hospitalization, incidence of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), and bronchopulmonary dysplasia (BPD). Statistical analysis was conducted by SPSS version 19 using means ± standard deviation, number (%), Chi-square test, and Independent-samples-t-test. Results: A total of 92 infants were enrolled, 46 in intervention and 46 in control group. Administration of IVIG as an adjunctive treatment significantly improved the prevalence of sepsis (0.0487; 95% CI, 0.0027-0.8711, pvalue=0.04) and C-reactive protein (0.1869; 95% CI, 0.0380-0.9194, p-value=0.0391) in intervention group in comparison with the control group. No significant differences were observed in IVH, BPD, and NEC between the experimental groups (p-value>0.05). Duration of hospitalization was 13.86 ± 7.31 days in IVIG group and 20.84 ± 11.93 days in control group (p-value<0.05). Conclusion: Prophylactic IVIG is effective in reducing nosocomial infections and duration of hospitalization in preterm and LBW neonates, but has no effect on IVH, BPD, and NEC. We recommend prophylactic IVIG in preterm infants with LBW. Trial registration: The trial is registered at the ClinicalTrials.gov with the identification number NCT02954926. Founding: The authors received financial support from Research

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Adjuvant use of intravenous immunoglobulin in the treatment of neonatal sepsis: a systematic review with a meta-analysis

Cited by 7 publications

References 20 publications

Intravenous Immunoglobulin in Neonatal Sepsis

Intravenous Immunoglobulin in Neonatal Sepsis

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis

Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis: A Clinical Trial Study

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