Clinical Trial: Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 4 Study of Use of High-dose Intravenous Immune Globulin for Prevent Hyperbilirubinemia Due Rh Hemolytic Disease in Newborns Infants
Brief Summary: The use of intravenous immunoglobulin G (IVIG) therapy has been reported in hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human Immunoglobulin is considered an alternative to delay the hemolytic process and consequently reduce the number of exchange transfusions and transfusions of red cells concentrate, thus diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To determine the effect of IVIG in decreasing the incidence and severity of neonatal immune hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical trial involving all newborns with risk of significant hyperbilirubinemia due to direct Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion and others are: incidence of late anemia, kernicterus and deafness Babies were randomly assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg); and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in the first 6 hours of life. Exchange transfusion was carried out in any group if at any time the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent will be asked in pre-natal time.
Detailed Summary:
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.
If the high incidence of the disease, the difficulties and the risks involved in an exchange transfusion, the difficulties in obtaining Rh
Sponsor: Oswaldo Cruz Foundation
Current Primary Outcome: Need of Exchange Transfusion [ Time Frame: 10 DAYS OF LIFE ]
Original Primary Outcome: Need of Exchange Transfusion
Current Secondary Outcome:
Original Secondary Outcome: incidence of late anemia, kernicterus and deafness
Information By: Oswaldo Cruz Foundation
Dates:
Date Received: February 6, 2006
Date Started: October 2006
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015
