Transfusion-Transmitted Cytomegalovirus Prevention in Neonates

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Blood Transfusion; Cytomegalovirus Infections

Treatments: Drug: immunoglobulins

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000584

304

R01HL029883-04 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.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.

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.