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

This study has been completed.
Sponsor:
Collaborator:
Instituto Fernandes Figueira
Information provided by:
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00288600
First received: February 6, 2006
Last updated: February 20, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Oswaldo Cruz Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Blood Group Incompatibility
Fetal Diseases
Hematologic Diseases
Immune System Diseases
Infant, Newborn, Diseases
Pathologic Processes
Pregnancy Complications
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Pharmaceutical Solutions
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014