Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000584
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Transfusion-Transmitted Cytomegalovirus Prevention in Neonates
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the capacity of intravenously administered cytomegalovirus CMV-immune globin CMVIG to immunize high risk premature infants against CMV infections
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of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL029883-04 | OTHER_GRANT | US NIH Grant Number | None |