Efficacy of two dose regimes of intravenous immunoglobulin in Rh hemolytic disease of newborn--a randomized controlled trial

Indian Pediatr. 2008 Aug;45(8):653-9.

Abstract

Objective: To compare the effect of two dose regimes of IVIg (0.5 g/kg vs. 1g/kg given soon after birth) on duration of phototherapy in Rh-isoimmunized neonates 32 week and above gestation.

Design: Randomized controlled trial.

Setting: Tertiary care hospital.

Subjects: Rh positive blood group neonates of gestation 32 weeks and above born to Rh negative mothers having positive Direct Coombs test and without any major malformation.

Intervention: Intravenous immunoglobulin (IVIg) infusion over 2 h either 0.5 g/kg (low dose group, n=19) or 1.0 g/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 of gestation 32 weeks and above.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Erythroblastosis, Fetal / drug therapy*
  • Humans
  • Immunoglobulins, Intravenous / therapeutic use*
  • Infant, Newborn
  • Rh-Hr Blood-Group System

Substances

  • Immunoglobulins, Intravenous
  • Rh-Hr Blood-Group System