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Transfusion-Transmitted Cytomegalovirus Prevention in Neonates

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ClinicalTrials.gov Identifier: NCT00000584
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin (CMVIG) to immunize high risk premature infants against CMV infections.

Condition or disease Intervention/treatment Phase
Blood Transfusion Cytomegalovirus Infections Drug: immunoglobulins Phase 3

Detailed Description:

BACKGROUND:

Premature infants who require multiple blood transfusions have a 15-30 percent incidence of cytomegalovirus infections. Many of these infections result in severe disease, with a mortality of about 20 percent. In theory, the infection could be avoided by using blood and blood products exclusively from CMV antibody negative donors. The use of such blood is impractical because it would require the rejection of approximately 40 percent of all blood donors. Studies had suggested that passively acquired antibody could reduce the incidence of disease in exposed neonates. This provided the rationale for the use of passive immunization with hyperimmune globin in premature infants likely to require multiple transfusions. Lots of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.

DESIGN NARRATIVE:

Randomized, double-blind. Subjects received either prophylactic CMVIG-intravenously or a placebo. Infants were followed for up to 12 weeks after discharge. Total sample size was expected to be 650.

The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : July 1983
Study Completion Date : June 1988






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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Neonates at high risk for transfusion-transmitted CMV infection. The neonates were either premature, of low birth weight, or had respiratory distress requiring the presence of an umbilical catheter.

Publications:
ClinicalTrials.gov Identifier: NCT00000584     History of Changes
Other Study ID Numbers: 304
R01HL029883-04 ( Other Grant/Funding Number: US NIH Grant Number )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: December 2005

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs