Cytomegalovirus Congenital Infection
Conditions
Keywords
congenital CMV infection, standard immunoglobulins, immunoglobulin therapy, IgG CMV avidity index, Cytomegalovirus
Brief summary
Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from unselected donor pools including a varying proportion of donors previously exposed to CMV - has not yet been explored in pregnant women, the investigators performed a longitudinal prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV infection.
Detailed description
Human IVIG are offered monthly to consecutive enrolled pregnant women with confirmed primary CMV infection at any stage, for the prevention and treatment of fetal CMV infection. Primary infection is defined by positive CMV IgM antibodies with absent or low titres of CMV IgG antibodies, and either low (\<40%) CMV IgG avidity indexes with positive CMV IgM AND IgG antibodies. In addition women with indefinite avidity index and positive CMV DNA detection in urine and/or blood samples are also considered for treatment. Standard human intravenous immunoglobulins were chosen for their safety and efficacy, well documented in other settings. IVIGs were used to perform all of the infusions in the study, undiluted after reconstitution, in accordance with instructions of the manufacturer. We chose to perform IVIG infusions using 0.5 g/Kg of body weight, to make sure that a dose of specific CMV IgG at least comparable with that carried by HIG were infused at each time point. Infusions last 4 to 5 hours, using a double lumen line to infuse approximately 1500 mL of either 5% glucose or saline solution in parallel with the undiluted IVIG preparation, to reduce the risk of infusion reactions. CMV IgG and IgM antibodies and IgG avidity indexes are assayed before and after each IVIG infusion, within 15 minutes. Quantitative CMV DNA is amplified from whole blood and urine samples from pregnant women and neonates, using the Real-Time PCR, and on samples of amniotic fluid from women who required amniocentesis. The newborns will be followed for five years after delivery.
Interventions
BIOLOGICALstandard intravenous immunoglobulin
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection
Sponsors
Regione Abruzzo, Italy
Azienda Sanitaria Locale di Pescara
Fondazione Onlus Camillo De Lellis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant women with confirmed primary CMV infection at any stage of gestation.
Exclusion criteria
* Pregnant women with falsely positive CMV IgM antibodies or high (\>40%) CMV IgG avidity indexes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of neurological damage due to Cytomegalovirus congenital infection | Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue | Number of infected newborns with neurological deficits divided by the total number of infected newborns |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection | Participants are followed during the infusion period, an expected average of 5 hours; possible minor side-effects are searched for at each follow up visit | Number of women with symptoms or adverse events during infusions divided by the total number of treated women |
Countries
Italy
Outcome results
None listed