Phase 4 Study of Use of High-dose Intravenous Immune Globulin for Prevent Hyperbilirubinemia Due Rh Hemolytic Disease in Newborns Infants

The Hemolytic Anemia due to Rh alloimmunization is characterized by the hemolysis of Rh (D) fetal red cells caused by the action of anti Rh (D) maternal antibodies in the fetal circulation.

The perinatal hemolytic disease due to Rh alloimmunization is almost extinct all over the world. The administration of Specific Human Immunoglobulin prevents the sensitization process and when introduced in the perinatal care of pregnant women, it reduces the incidence of cases of Rh alloimmunization.

Unfortunately Brazil does not have effective policies geared to reducing the perinatal hemolytic disease and its consequences and thus the incidence of this condition continues to be high.

The conventional treatment includes phototherapy and exchange transfusion. The advantages of the exchange transfusion in the Rh hemolytic disease are well defined but its risks remain high and the mortality rates related to the procedure range around 2% and the morbimortality (thrombocytopenia, thrombosis of the portal vein, necrotizing enterocolitis, metabolic disorders and infection) reach 12%. The procedure requires the availability of compatible blood, a team with appropriate training in the procedure and a neonatal ICU infrastructure prepared to prevent the admission of newborns whose mothers did not go through prophylaxis.

The use of immunoglobulin associated to phototherapy may reduce the need for exchange transfusion, thus allowing for more sensitized newborns to receive treatment and therefore avoiding neurological damages associated with the hemolytic disease.