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NCT00907686 · ClinicalTrials.gov registry record
TT-CMV Observational Birth Cohort Study
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 600
- Enrollment target
NCT00907686: Completed study, sponsored by Emory University.
NCT00907686 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 600 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00907686 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
Study Summary
The spread of viruses through transfusions is the cause of serious illness and death in recipients whose immune systems are unable to fight infection. Another group of patients whose immune systems are underdeveloped and can be affected by a particular virus known as cytomegalovirus (CMV) is low birthweight infants (LBWIs). CMV can be spread through the placenta, during the birth process, through breast milk, while in the hospital or while caring for someone carrying the virus as well as through a transfusion, known as transfusion-transmitted (TT-CMV). The spread of TT-CMV in LBWIs can be curtailed by transfusing blood products that are CMV negative as well as to filter the white cells in blood that carry the virus (leukoreduction). The purpose of this study is to see if the use of these two strategies can lower the spread of CMV through a transfusion. How "safe" the blood actually is through leukoreduction is not known and CMV still occurs in LBWIs. It is not clear whether this approach is optimal or whether additional safety steps are needed to completely prevent TT-CMV. Specific actions that could tell us when virus has reached the blood product or breast milk is to test each of these to determine if virus slipped "unnoticed" and/or when the product was not thoroughly filtered. In this study, the investigators believe that the use of both prevention strategies will result in a lower rate of TT-CMV, and that the "cause" of TT-CMV may be found in the presence of CMV at the DNA level or by unfiltered white cells that remain in the blood product. Thus, the most significant clinical question that remains to be addressed is whether this double strategy for transfusion safety actually provides a "zero CMV-risk" blood supply or whether further safety measures (DNA testing + 100% leukoreduction) must be used to protect this extremely vulnerable patient group from CMV infection. This birth cohort study will be done with 6 participating NICUs, and will study both CMV posi
Primary Outcome
The effectiveness of these two strategies coupled together will be assessed in the prevention of TT-CMV in at-risk LBWI born to CMV-negative and CMV-positive mothers.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-04 |
What the finished NCT00907686 record still lists
NCT00907686 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00907686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00907686 about?
NCT00907686 is a clinical study titled "TT-CMV Observational Birth Cohort Study". The spread of viruses through transfusions is the cause of serious illness and death in recipients whose immune systems are unable to fight infection. Another group of patients whose immune systems are underdeveloped and can be affected by a particular virus known as cytomegalovirus (CMV) is low bir...
What is the current status of trial NCT00907686?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2010-01. Estimated completion is 2014-04.
Who is sponsoring clinical trial NCT00907686?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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