USE OF CYTOMEGALOVIRUS IMMUNOGLOBULIN IN MULTIPLY TRANSFUSED PREMATURE NEONATES

We undertook a randomized, placebo-controlled, double blind trial of c ytomegalovirus (CMV) immunoglobulin (CMVIG) for prevention of CMV-asso ciated disease in 183 multiply transfused, premature neonates. CMVIG ( 150 mg/kg) or placebo was given within 24 hours of the first transfusi on and at Day 10, If an intravenous catheter was still in place an add itional dose was given between Days 20 and 30. The globulin and placeb o groups were well-matched with respect to birth weight, gestational a ge, Apgar score, birth to a CMV-seropositive mother, requirement for a ssisted ventilation and exposure to CMV-positive, unscreened blood pro ducts. Among infants followed for more than 10 days, 18 (10.5%) develo ped CMV infection; 9 had symptomatic CMV disease (5 placebo; 4 CMVIG). Among infants born to a CMV-seropositive mother, CMVIG use was associ ated with a CMV syndrome rate of 3.2% (95% confidence interval, 0.2 to 18.5%) compared to 12.5% (95% confidence interval, 4.5 to 27.6%) amon g placebo recipients (P = 0.163). Among placebo recipients infants bor n to CMV-seropositive mothers were more likely to have a virologically confirmed CMV syndrome than those born to a CMV seronegative mother, despite receipt of blood not screened for CMV antibody (P = 0.012). Mu ltivariate analysis demonstrated that two factors were independently a ssociated with CMV acquisition: the volume of CMV-seropositive blood p roducts transfused (P = 0.005); and birth to a CMV-seropositive mother (P = 0.006). Infusions of CMVIG were well-tolerated, This study reaff irms that perinatally acquired CMV disease is more common among infant s born to CMV-seropositive mothers than CMV-seronegative mothers, even without use of CMV-screened blood products.