Intravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial.

Traditional neonatal treatment of Rhesus (Rh) hemolytic disease consists of intensive phototherapy and exchange transfusions (ET). Recently, routine use of intravenous immunoglobulin (IVIg) has been recommended to reduce the number of ET. However, the evidence to recommend prophylactic treatment with IVIg is limited.
The aim of this study is to determine whether the prophylactic use of IVIg reduces the need for ET in neonates with Rh (D) or (c) hemolytic disease. The study design is a prospective randomized double blind placebo controlled trial. All neonates born at our hospital after 35 weeks’ gestation and affected with Rh (D) or (c) disease are eligible for the study. After parental informed consent and randomization, neonates will receive conventional treatment + IVIg (0.75 g/kg) or conventional treatment alone. Primary outcome is the proportion of children requiring ET and number of ET performed per infant. Secondary outcomes are duration of phototherapy and hospital stay, serum bilirubin levels (maximum values and change within first 24 and 48 hours), proportion of children requiring top-up red cell transfusion within the first three months of life and the number of red cell transfusions per infant.

A randomized double blind placebo controlled trial for the use of intravenous immunoglobulin to reduce the number of exchange transfusions in Rhesus disease of the neonate.

Study group: prophylactic IvIG as a single dose of 0.75 g/kg within the first 4 hours after birth;
Control group: an equal amount of glucose 5% intravenous infusion (placebo).