Efficacy of IgM-Rich Immunoglobin for Treating Bacterial Sepsis in Very-Low-Birth-Weight Preterm Neonates
Sonal Vijay Jindal, Jayendra Ratilal Gohil, Adithya Nikhileshwar
Abstract
Background and Aim: Preterm neonates have a 3- to 10-fold higher incidence of infections than full-term, normal-birthweight neonates. A 2010 Cochrane meta-analysis demonstrates that intravenous immunoglobulin significantly reduces mortality in neonates with suspected or proven infection. However, there is insufficient evidence for routine use of IgM-rich intravenous immunoglobulin (IgM-IVIG) to treat neonatal sepsis in preterm neonates. The aim was to compare the efficacy of IgM-IVIG in culture-proven bacterial sepsis in preterm, very-low-birth-weight neonates (1 to 1.5 kg).
Materials and Methods: Overall, 110 neonates with probable sepsis, after matching the inclusion and exclusion criteria, were treated according to the standard NICU sepsis guidelines in a NICU at Sir Takhtasinhji General Hospital (Bhavnagar, Gujarat). Of them, 60 neonates with culture-proven sepsis were selected and were divided randomly into 2 groups: IgM-IVIG group (received standard sepsis therapy and immunoglobulin) and control group (received standard sepsis therapy, but no immunoglobulin).
Results: There was a significant reduction in mortality in the group of neonates receiving IgM-IVIG along with antibiotics (20%, n = 6) compared with the group receiving only antibiotics (46.7%, n = 14; OR = 3.5; 95% CI: 1.11–11; P = .028). Generalized edema and hypoalbuminemia were seen in 1 neonate who received immunoglobulin. There was no significant decrease in the duration of hospitalization.
Conclusion: IgM-IVIG, as an adjunct to antibiotics, in culture-proven sepsis decreased mortality significantly.
Clinical Trial Registration: Clinicaltrials.gov/NCT03403530
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