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

NCT00288600 | Completed Phase 4 Results DMC

• 1 other identifier: ivig01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperbilirubinemia; Erythroblastosis, Fetal

Keywords

Immunoglobulins, Intravenous; Hyperbilirubinemia; Erythroblastosis, Fetal; Exchange Transfusion, Whole Blood

Outcome Measures

Primary Outcomes (1)

• Need of Exchange Transfusion

  NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES

  10 DAYS OF LIFE

Study Arms (2)

Experimental group

EXPERIMENTAL

Intravenous Immunoglobulin

Drug: Intravenous Immunoglobulin

CONTROL GROUP

PLACEBO COMPARATOR

Normal Saline solution

Drug: Normal saline solution

Interventions

Intravenous Immunoglobulin DRUG

Intravenous Immunoglobulin

Also known as: Immunoglobulin

Experimental group

Normal saline solution DRUG

Normal saline solution 10 ml/Kg

Also known as: saline solution

CONTROL GROUP

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• Instituto Fernandes Figueira: collaborator

Study Sites (1)

Maria Elisabeth L Moreira

Rio de Janeiro, Rio de Janeiro, 22420040, Brazil

Location

Related Publications (1)

• Santos MC, Sa C, Gomes SC Jr, Camacho LA, Moreira ME. The efficacy of the use of intravenous human immunoglobulin in Brazilian newborns with rhesus hemolytic disease: a randomized double-blind trial. Transfusion. 2013 Apr;53(4):777-82. doi: 10.1111/j.1537-2995.2012.03827.x. Epub 2012 Aug 6.

  PMID: 22882285 RESULT

MeSH Terms

Conditions

Hyperbilirubinemia; Erythroblastosis, Fetal

Interventions

Immunoglobulins, Intravenous; Immunoglobulins; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

We calculated the sample size using a expected rate of 30% reduction in exchange using incidence of exchange transfusion at our department and data from a meta-analysis (relative risk, 0.21; 95% CI 0.10-0.45).

Results Point of Contact

• Title: Maria Elisabeth Moreira
• Organization: Fundação Oswaldo Cruz

bebeth@iff.fiocruz.br

552125541911

Study Officials

• Maria EL Moreira, MD

  Oswaldo Cruz Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 8, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 8, 2016
• Results First Posted: January 8, 2016

Record last verified: 2015-12

Locations

BR (1)