EFFECT OF INTRAVENOUS IMMUNOGLOBULIN IN PREVENTION OF PRETERM NEONATAL SEPSIS: A CLINICAL TRIAL STUDY

Abstract

Abstract

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, p- value=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 Deputy of Hormozgan University of Medical Sciences.