Efficacy of two dose regimes of intravenous immunoglobulin in Rh hemolytic disease of newborn: A randomized controlled trial

Abstract

Objective: To compare the effect of two dose regimes of IVIg (0.5g/kg vs. 1g/kg given soon after birth) on duration of phototherapy in Rh-isoimmunized neonates ³32 week gestation. Design: Randomized controlled trial. Setting: Tertiary care hospital. Subjects: Rh positive blood group neonates of ³32 week gestation born to Rh negative mother having positive Direct Coomb’s test and without any major malformation. Intervention: Intravenous immunoglobulin (IVIg) infusion over 2 h either 0.5g/kg (low dose group, n=19) or 1.0g/kg (high dose group, n=19). Primary outcome variable: Duration of phototherapy. Results: The mean duration of phototherapy was 77.3±57.2 h in low dose group versus 55.4±49 h in high dose group (mean difference = 21.9; 95% CI - 13.1 to 56.9). There was no difference in need for exchange transfusion (21% in both the groups) and requirement of packed red blood cells transfusion (12 transfusions in both groups). The duration of hospital stay was similar [8.4±6.9 and 13.6±14.8 days, respectively (mean difference = - 5.1; 95% CI -12.8 to 2.5)]. No adverse effects of IVIg administration were noted. Conclusion: Two regimens of IVIg (0.5 g/Kg or 1 g/Kg) had comparable effect on duration of phototherapy, duration of hospital stay and exchange transfusion requirement, in Rh isoimmunized neonates ³32 weeks of gestation.