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Sponsors and Collaborators: |
Oswaldo Cruz Foundation FAPERJ |
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Information provided by: | Oswaldo Cruz Foundation |
ClinicalTrials.gov Identifier: | NCT00288600 |
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) in group 2. Adverse effects will be related in two groups. Parents informed consent will be asked in pre-natal time.
Condition | Intervention | Phase |
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Hyperbilirubinemia Erythroblastosis, Fetal |
Drug: Intravenous Immunoglobulin Drug: Normal saline solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 4 Study of Use of High-Dose Intravenous Immune Globulin for Prevent Hyperbilirubinemia Due Rh Hemolytic Disease in Newborns Infants |
Estimated Enrollment: | 140 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimental group: Experimental
Intravenous Immunoglobulin
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Drug: Intravenous Immunoglobulin
Intravenous Immunoglobulin
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2: Placebo Comparator
Normal Saline solution
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Drug: Normal saline solution
Normal saline solution 10 ml/Kg
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Ages Eligible for Study: | up to 6 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria EL Moreira, MD | 55-21-25541819 | bebeth@iff.fiocruz.br |
Contact: Maria C Pessoa, MD | 25541700 ext 1890 | crispessoa@uol.com.br |
Brazil | |
Maria Elisabeth L Moreira | Recruiting |
Rio de janeiro, Brazil, 22420040 | |
Contact: Maria E Moreira, MD 552125132224 bebeth@iff.fiocruz.br | |
Sub-Investigator: Cynthia A Sá, MD |
Principal Investigator: | Maria EL Moreira, MD | Oswaldo Cruz Foundation |
Responsible Party: | Oswaldo cruz Foundation ( Maria Elisabeth Lopes Moreira ) |
Study ID Numbers: | ivig01 |
Study First Received: | February 6, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00288600 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Immunoglobulins, Intravenous Hyperbilirubinemia Erythroblastosis, Fetal Exchange Transfusion, Whole Blood |
Erythroblastosis, Fetal Antibodies Fetal Diseases Pregnancy Complications Immunologic Factors Immunoglobulins, Intravenous |
Hematologic Diseases Hyperbilirubinemia Rho(D) Immune Globulin Infant, Newborn, Diseases Immunoglobulins |
Erythroblastosis, Fetal Pregnancy Complications Immunologic Factors Immune System Diseases Hematologic Diseases Physiological Effects of Drugs Blood Group Incompatibility Pharmacologic Actions |
Fetal Diseases Antibodies Pathologic Processes Immunoglobulins, Intravenous Hyperbilirubinemia Infant, Newborn, Diseases Rho(D) Immune Globulin Immunoglobulins |