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| Sponsors and Collaborators: |
Oswaldo Cruz Foundation FAPERJ |
| Information provided by: | Oswaldo Cruz Foundation |
| ClinicalTrials.gov Identifier: | NCT00288600 |
Purpose
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 |
|
Hyperbilirubinemia Erythroblastosis, Fetal |
Drug: Intravenous Immunoglobulin Drug: Normal saline solution |
Phase IV |
| MedlinePlus related topics: | Anemia Blood Transfusion and Donation Hearing Disorders and Deafness Jaundice |
| ChemIDplus related topics: | Globulin, Immune Immunoglobulins Sodium chloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group 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: | February 2009 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Oswaldo Cruz Foundation |
| FAPERJ |
| Principal Investigator: | Maria EL Moreira, MD | Oswaldo Cruz Foundation |
More Information
| Study ID Numbers: | ivig01 |
| First Received: | February 6, 2006 |
| Last Updated: | November 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00288600 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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