The CONCERT study CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial
- Conditions
- congenital cytomegalovirus (CMV)100407921001924310012562
- Registration Number
- NL-OMON39229
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- Infants with congenital CMV infection, and hearing loss (>= 20 dB, in one or both ears).
- Age at time of inclusion is <= 12 weeks after birth.
- >= 37 weeks gestational age.
- Birth weight >= 2500 gram.
- Parental signed informed consent.
- Indications for symptomatic congenital CMV infection based on diagnostics carried out prior to the inclusion of the child in the trial.
- In case during the house visit the presence of a symptomatic CMV infection is doubted, inclusion will be discussed. Depending on the medical history taking, physical examination and laboratory tests inclusion will be decided upon.
- Treatment with other antiviral agents or immunoglobulins.
- Leucopenia < 0,5 x 10*9/L (blood sample tested at t=0).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the status of the sensorineural hearing loss expressed<br /><br>in dB, in children with congenital CMV at 1 year follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are development (cognitive and motor) at baseline and 1<br /><br>year follow-up. Communicative and speech development will be assessed at 1 year<br /><br>follow-up. Furthermore, for the treatment group the viral load in blood and<br /><br>urine will be determined at baseline and thereafter weekly during the 6 weeks<br /><br>of treatment and at 1 week after completion of treatment. For the non-treatment<br /><br>group blood viral load will be determined at two time points (t=0 and 6 weeks),<br /><br>and urine viral load will be determined weekly during the 7 weeks after<br /><br>inclusion. At 1 year follow-up the urine viral load will be determined for all<br /><br>included children.</p><br>