Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease - Full Text View

Sponsor:	Oswaldo Cruz Foundation
Collaborator:	Instituto Fernandes Figueira
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). 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

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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Hearing Disorders and Deafness Jaundice Rh Incompatibility

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:

need of exchange transfusion [ Time Frame: 10 days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

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Eligibility

Ages Eligible for Study:	up to 6 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288600

Locations

Brazil
Maria Elisabeth L Moreira
Rio de janeiro, Brazil, 22420040

Sponsors and Collaborators

Oswaldo Cruz Foundation

Instituto Fernandes Figueira

Investigators

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 February 12, 2012