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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000584
Other study ID # 304
Secondary ID R01HL029883-04
Status Completed
Phase Phase 3
First received October 27, 1999
Last updated November 25, 2013
Start date July 1983
Est. completion date June 1988

Study information

Verified date December 2005
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 1988
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility 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.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
immunoglobulins


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

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. — View Citation

Snydman DR. Prevention of cytomegalovirus-associated diseases with immunoglobulin. Transplant Proc. 1991 Jun;23(3 Suppl 3):131-5, discussion 135. Review. — View Citation

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