Intravenous immunoglobulin in the treatment of rhesus disease of the neonate: a randomised double blind placebo controlled trial

INTERVENTION: Study group: prophylactic IvIG as a single dose of 0.75 g/kg within the first four hours after birth. Control group: an equal amount of glucose 5% intravenous infusion (placebo). CONDITION: Rhesus disease ; Pregnancy and Childbirth ; Foetal problems PRIMARY OUTCOME: 1. Use of exchange transfusion (% proportion of children receiving one or more exchange transfusion); 2. Number of exchange transfusion performed per infant SECONDARY OUTCOME: 1. Duration of phototherapy (number of days); 2. Maximum serum bilirubin (mmol/l); 3. Change in bilirubin in first 24 hours (%); 4. Change in bilirubin in first 48 hours (%); 5. Use of top‐up red cell transfusion in first week of life (% proportion of children receiving one or more red cell transfusion and number of transfusions per infant); 6. Use of simple red cell transfusion after first week and until three months of life (% proportion of children receiving one or more red cell transfusion and number of transfusions per infant); 7. Duration of hospital stay (number of days) INCLUSION CRITERIA: Neonates of 35 or more weeks of gestation with Rhesus hemolytic disease admitted to the neonatal nursery of the Leiden University Medical Center (LUMC). Rhesus hemolytic disease was defined as: 1. Antibody Dependent Cellular Cytotoxicity‐test (ADCC) more than 50%, and 2. Positive direct Coombs test in a Rh (D) or (c) positive fetus/neonate with a Rh (D) or (c) negative mother respectively and a Rh (D) or (c) positive father respectively. Previous intra‐uterine transfusions and the presence of additional antibodies besides anti‐D and anti‐c are not reasons for exclusion