Transfusion-Transmitted Cytomegalovirus Prevention in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00000584|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Blood Transfusion Cytomegalovirus Infections||Drug: immunoglobulins||Phase 3|
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of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.
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)|
|Study Start Date :||July 1983|
|Study Completion Date :||June 1988|