Congenital cytomegalovirus infection. Sensorineural Hearingloss. MedDRA version: 18.0 Level: LLT Classification code 10010420 Term: Congenital CMV infection System Organ Class: 100000004850
Conditions
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment group and refusal control group - 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. - Born at = 37 weeks gestational age. - Birth weight = 2500 gram. - Parental signed informed consent. Historical control group - Infants with congenital CMV infection, and hearing loss (= 20 dB, in one or both ears). - Age at time of inclusion is > 13 weeks after birth. - Born at = 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: Treatment group and refusal control group - Previously noted (= 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested. For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin. - Treatment with other antiviral agents or immunoglobulins. - Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested at t=0). Historical control group - Previously encountered (= 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin. - Treatment with (val)ganciclovir. - Treatment with other antiviral agents or immunoglobulins.
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 18-22 months 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 during 6 weeks treatment and one week after completion of treatment. At age 18-22 months (follow-up) solely the urine sample will be investigated for the viral load. 3) Investigate whether drug resistance has evolved.;Primary end point(s): The primary endpoint is the status of the sensorineural hearing loss expressed in dB, in children with congenital CMV at age 18-22 months follow-up.;Timepoint(s) of evaluation of this end point: Hearing loss will be evaluated at age 18-22 months. | — |
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 age 18-22 months follow-up (for infants in the treatment and refusal control group). For infants in the historical control group materials collected previously will be tested when available. The final endpoint is the possibility of development of drug resistance.;Timepoint(s) of evaluation of this end point: The development of the infants will be tested at age 18-22 months follow-up. For treated infants and infants in the refusal control group 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 age 18-22 months follow-up the viral load will be determined in urine for all infants (also the infants in the historical control group). | — |
Countries
Netherlands
Contacts
Public ContactFleurtje Schornagel
LUMC
Outcome results
None listed