TT-CMV Observational Birth Cohort Study

NCT00907686 | Completed DMC

• 3 other identifiers: IRB00014684P01HL086773-01A1NCT00907686
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

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 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 positive and negative mothers in order to estimate the rate and pathway of CMV transmission to the LBWI who receives a transfusion. Another study goal is to compare or link any CMV infection by either transfused units where the virus was undetected, or filter failure. If CMV disease occurs, the investigators will be able to describe the course and outcome in LBWIs who develop TT-CMV.

Conditions

Cytomegalovirus Disease

Keywords

Transfusion Transmitted Cytomegalovirus (TT-CMV); Low birthweight infants (LBWIs); Leukoreduction and filter failure; CMV Seronegative blood products

Outcome Measures

Primary Outcomes (1)

• Estimate the incidence of TT-CMV in LBWIs who receive CMV-seronegative plus leukoreduced blood products.

  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.

  90 days study observation

Study Arms (2)

LBWIs of CMV-positive mother

LBWIs born to CMV-positive mothers

CMV Sero-negative & Sero-postive LBWIs

LBWIs of CMV sero-negative \& sero-positive mothers

Eligibility Criteria

• Age: 1 Hour - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Low birthweight infants in NICU.

You may qualify if:

• All LBWIs whose weight is ≤ 1500 grams at birth
• LBWI is within first five days of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Northside Hospital

Atlanta, Georgia, 30328, United States

Location

Related Publications (2)

• Josephson CD, Caliendo AM, Easley KA, Knezevic A, Shenvi N, Hinkes MT, Patel RM, Hillyer CD, Roback JD. Blood transfusion and breast milk transmission of cytomegalovirus in very low-birth-weight infants: a prospective cohort study. JAMA Pediatr. 2014 Nov;168(11):1054-62. doi: 10.1001/jamapediatrics.2014.1360.

  PMID: 25243446 DERIVED

• Josephson CD, Castillejo MI, Caliendo AM, Waller EK, Zimring J, Easley KA, Kutner M, Hillyer CD, Roback JD. Prevention of transfusion-transmitted cytomegalovirus in low-birth weight infants (</=1500 g) using cytomegalovirus-seronegative and leukoreduced transfusions. Transfus Med Rev. 2011 Apr;25(2):125-32. doi: 10.1016/j.tmrv.2010.11.004. Epub 2011 Feb 23.

  PMID: 21345642 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood, Urine, Breast Milk

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Cassandra Josephson, MD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (3)