Congenital cytomegalovirus infection. Sensorineural Hearingloss. MedDRA version: 14.1 Level: LLT Classification code 10010420 Term: Congenital CMV infection System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants with congenital CMV infection, and hearing loss (=20 dB, in one or both ears). • Age at time of inclusion is 37 weeks gestational age. • Birth weight >2500 gram. • Parental signed informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 1 year follow-up.;Secondary Objective: 1) Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent cognitive and motor retardation. Communicative and speech development will be extensively assessed. 2) Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection reduces the CMV viral load in urine and blood samples 6 weeks treatment and one week and one year after completion of treatment. At 1 year follow-up solely the urine sample will be investigated for the viral load.;Primary end point(s): The primary endpoint is the status of the sensorineural hearing loss expressed in dB, in children with congenital CMV at 1 year follow-up.;Timepoint(s) of evaluation of this end point: The hearing loss will be evaluated at 1 year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is the development of the infants. The tertiary endpoint is the viral load (in dried blood spots, blood and urine) during 7 weeks after inclusion and at 1 year follow-up.;Timepoint(s) of evaluation of this end point: The development of the infants will be tested at 1 year follow-up. The viral load will be determined at inclusion and weekly in urine during the first 7 weeks after inclusion (total 8 moments). For treated infants it will be determined at inclusion and weekly in blood samples (total 8 moments). For untreated infants it will be determined twice in blood (at inclusion and in week 6). At 1 year follow-up the viral load will be determined in urine for all infants. | — |
Countries
Netherlands
Contacts
Public ContactFleurtje Schornagel
LUMC
Outcome results
None listed