Status:
COMPLETED
TT-CMV Observational Birth Cohort Study
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cytomegalovirus Disease
Eligibility:
All Genders
1-5 years
Brief 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 ar...
Detailed Description
The primary aim of this birth cohort study is to estimate the incidence of TT-CMV in LBWIs who receive a combination of CMV-seronegative + leukoreduced blood products. That is to say, the effectivenes...
Eligibility Criteria
Inclusion
- All LBWIs whose weight is ≤ 1500 grams at birth
- LBWI is within first five days of life
Exclusion
- LBWI not expected to live past first seven days of life
- LBWI has a severe congenital abnormality
- LBWI has received a RBC or platelet transfusion at another institution prior to transfer
- LBWI has received an in-utero transfusion
- LBWI is clinically suspected of having toxoplasmosis, rubella, herpes infection(s) at birth
- Refusal by the mother to grant consent for herself and/or refusal to grant consent for her LBWI
- If the mother of the child has previously participated in this study
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00907686
Start Date
January 1 2010
End Date
April 1 2014
Last Update
June 26 2015
Active Locations (3)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Northside Hospital
Atlanta, Georgia, United States, 30328