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Efficacy of High-Dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
This study is currently recruiting participants.
Verified by Oswaldo Cruz Foundation, April 2009
First Received: February 6, 2006   Last Updated: April 2, 2009   History of Changes
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
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
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

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 ]

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
Experimental group: Experimental
Intravenous Immunoglobulin
Drug: Intravenous Immunoglobulin
Intravenous Immunoglobulin
2: Placebo Comparator
Normal Saline solution
Drug: Normal saline solution
Normal saline solution 10 ml/Kg

  Show Detailed Description

  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

Contacts
Contact: Maria EL Moreira, MD 55-21-25541819 bebeth@iff.fiocruz.br
Contact: Maria C Pessoa, MD 25541700 ext 1890 crispessoa@uol.com.br

Locations
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            
Sponsors and Collaborators
Oswaldo Cruz Foundation
FAPERJ
Investigators
Principal Investigator: Maria EL Moreira, MD Oswaldo Cruz Foundation
  More Information

No publications provided

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

Keywords provided by Oswaldo Cruz Foundation:
Immunoglobulins, Intravenous
Hyperbilirubinemia
Erythroblastosis, Fetal
Exchange Transfusion, Whole Blood

Study placed in the following topic categories:
Erythroblastosis, Fetal
Antibodies
Fetal Diseases
Pregnancy Complications
Immunologic Factors
Immunoglobulins, Intravenous
Hematologic Diseases
Hyperbilirubinemia
Rho(D) Immune Globulin
Infant, Newborn, Diseases
Immunoglobulins

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009