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Use of cytomegalovirus immunoglobulin in multiply transfused premature neonates
D R Snydman1, B G Werner, H C Meissner
1Department of Medicine, New England Medical Center, Boston, MA 02111, USA.
Abstract:
We undertook a randomized, placebo-controlled, double blind trial of cytomegalovirus (CMV) immunoglobulin (CMVIG) for prevention of CMV-associated disease in 183 multiply transfused, premature neonates. CMVIG (150 mg/kg) or placebo was given within 24 hours of the first transfusion and at Day 10. If an intravenous catheter was still in place an additional dose was given between Days 20 and 30. The globulin and placebo groups were well-matched with respect to birth weight, gestational age, Apgar score, birth to a CMV-seropositive mother, requirement for assisted ventilation and exposure to CMV-positive, unscreened blood products. Among infants followed for more than 10 days, 18 (10.5%) developed CMV infection; 9 had symptomatic CMV disease (5 placebo; 4 CMVIG). Among infants born to a CMV-seropositive mother, CMVIG use was associated 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%) among placebo recipients (P = 0.163). Among placebo recipients infants born 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). Multivariate analysis demonstrated that two factors were independently associated with CMV acquisition: the volume of CMV-seropositive blood products transfused (P = 0.005); and birth to a CMV-seropositive mother (P = 0.006). Infusions of CMVIG were well-tolerated. This study reaffirms that perinatally acquired CMV disease is more common among infants born to CMV-seropositive mothers than CMV-seronegative mothers, even without use of CMV-screened blood products.
Insights
Cytomegalovirus (CMV) immunoglobulin (CMVIG) did not significantly prevent CMV disease in premature infants. However, CMVIG showed a trend toward reduced CMV syndrome in infants born to CMV-seropositive mothers.
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Immunology
Background:
- Premature neonates receiving multiple transfusions are at high risk for cytomegalovirus (CMV) infection.
- CMV infection can lead to significant morbidity and mortality in this vulnerable population.
- Preventive strategies for CMV in neonates are crucial.
Purpose of the Study:
- To evaluate the efficacy of cytomegalovirus immunoglobulin (CMVIG) in preventing CMV-associated disease in multiply transfused premature neonates.
- To assess the safety and tolerability of CMVIG infusions in this patient group.
Main Methods:
- A randomized, placebo-controlled, double-blind trial involving 183 premature neonates.
- Participants received either CMVIG (150 mg/kg) or placebo within 24 hours of the first transfusion, with additional doses as needed.
- Infants were monitored for CMV infection and associated disease.
Main Results:
- CMV infection occurred in 10.5% of infants followed for over 10 days, with 5 placebo recipients and 4 CMVIG recipients developing symptomatic CMV disease.
- Among infants born to CMV-seropositive mothers, CMVIG use was associated with a lower CMV syndrome rate (3.2%) compared to placebo (12.5%), though not statistically significant (P = 0.163).
- Independent risk factors for CMV acquisition included the volume of CMV-seropositive blood products transfused and birth to a CMV-seropositive mother.
Conclusions:
- CMVIG infusions were well-tolerated in premature neonates.
- While not statistically significant, CMVIG showed a potential trend towards reducing CMV syndrome in infants born to CMV-seropositive mothers.
- The study reinforces that infants born to CMV-seropositive mothers are at higher risk for perinatally acquired CMV disease, irrespective of blood screening practices.