At a glance
ClinicalIndex Comparison Record- ✓Gestational age ≥32 weeks
- ✓Rh(D) positive blood type
- ✓Born to sensitized Rh(D) negative mothers
- ✓Prior intrauterine transfusion status does not affect eligibility
- ✕Serious clinical condition at birth
- ✕Hydrops fetalis or hemodynamic instability
- ✕Indication for exchange transfusion at birth (cord bilirubin ≥4 mg%, hydrops, or cardiac insufficiency from severe anemia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 4 Study of Use of High-dose Intravenous Immune Globulin for Prevent Hyperbilirubinemia Due Rh Hemolytic Disease in Newborns Infants
In Brief
A Phase 4 clinical trial evaluating Intravenous Immunoglobulin and Normal saline solution for Hyperbilirubinemia and Erythroblastosis, Fetal. Completed, enrolled 92 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intravenous Immunoglobulin
Normal saline solution 10 ml/Kg