Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
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.