Transfusion-Transmitted Cytomegalovirus Prevention in Neonates
NCT ID: NCT00000584
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1983-07-31
1988-06-30
Brief Summary
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Detailed Description
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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of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.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.
Conditions
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Study Design
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RANDOMIZED
PREVENTION
DOUBLE
Interventions
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immunoglobulins
Eligibility Criteria
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Inclusion Criteria
1 Year
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
References
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Snydman DR. Prevention of cytomegalovirus-associated diseases with immunoglobulin. Transplant Proc. 1991 Jun;23(3 Suppl 3):131-5, discussion 135. No abstract available.
Snydman DR, Werner BG, Meissner HC, Cheeseman SH, Schwab J, Bednarek F, Kennedy JL Jr, Herschel M, Magno A, Levin MJ, et al. Use of cytomegalovirus immunoglobulin in multiply transfused premature neonates. Pediatr Infect Dis J. 1995 Jan;14(1):34-40. doi: 10.1097/00006454-199501000-00007.
Other Identifiers
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R01HL029883-04
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
304
Identifier Type: -
Identifier Source: org_study_id