Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
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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). 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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of Use of High-dose Intravenous Immune Globulin for Prevent Hyperbilirubinemia Due Rh Hemolytic Disease in Newborns Infants |
- need of exchange transfusion [ Time Frame: 10 days of life ] [ Designated as safety issue: Yes ]
- incidence of late anemia, kernicterus and deafness [ Time Frame: 1 year of life ] [ Designated as safety issue: Yes ]
| Enrollment: | 140 |
| Study Start Date: | October 2006 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental group
Intravenous Immunoglobulin
|
Drug: Intravenous Immunoglobulin
Intravenous Immunoglobulin
Other Name: Immunoglobulin
|
|
Placebo Comparator: 2
Normal Saline solution
|
Drug: Normal saline solution
Normal saline solution 10 ml/Kg
Other Name: saline solution
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Brazil | |
| Maria Elisabeth L Moreira | |
| Rio de janeiro, Brazil, 22420040 | |
| Principal Investigator: | Maria EL Moreira, MD | Oswaldo Cruz Foundation |
More Information
No publications provided
| Responsible Party: | Maria Elisabeth Lopes Moreira, Oswaldo cruz Foundation |
| ClinicalTrials.gov Identifier: | NCT00288600 History of Changes |
| Other Study ID Numbers: | ivig01 |
| Study First Received: | February 6, 2006 |
| Last Updated: | February 20, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Oswaldo Cruz Foundation:
|
Immunoglobulins, Intravenous Hyperbilirubinemia Erythroblastosis, Fetal Exchange Transfusion, Whole Blood |
Additional relevant MeSH terms:
|
Erythroblastosis, Fetal Hyperbilirubinemia Rh Isoimmunization Fetal Diseases Pregnancy Complications Blood Group Incompatibility Hematologic Diseases Infant, Newborn, Diseases Immune System Diseases |
Pathologic Processes Immunoglobulins Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013