Status:
COMPLETED
Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
Instituto Fernandes Figueira
Conditions:
Hyperbilirubinemia
Erythroblastosis, Fetal
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
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 ...
Detailed Description
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 perin...
Eligibility Criteria
Inclusion
- All newborns with a gestational age equal or higher than 32 weeks, with a Rh (D) positive blood type, children of sensitized Rh (D) negative mothers, regardless if they were submitted or not to an intra-uterus transfusion.
Exclusion
- Newborns in serious condition, hydropic, hemodynamically instable or with indication for exchange transfusion at birth. The indications for exchange transfusion at birth are: presence of bilirubin in the umbilical cord higher or equal to 4mg%; hydrops, cardiac insufficiency secondary to severe anemia.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00288600
Start Date
October 1 2006
End Date
August 1 2010
Last Update
January 8 2016
Active Locations (1)
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1
Maria Elisabeth L Moreira
Rio de Janeiro, Rio de Janeiro, Brazil, 22420040