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Efficacy of High-Dose Intravenous Immune Globulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease

This study is currently recruiting participants.
Verified by Oswaldo Cruz Foundation, November 2006

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   

U.S. FDA Resources

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

Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • need of exchange transfusion

Secondary Outcome Measures:
  • incidence of late anemia, kernicterus and deafness

Estimated Enrollment:   140
Study Start Date:   October 2006
Estimated Study Completion Date:   February 2009

Show detailed description  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


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

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

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

Additional relevant MeSH terms:
Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Blood Group Incompatibility
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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