NL-OMON41461
Completed
Phase 3
CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group - CONCERT study 2.0
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 11 (—)
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 \> \-2 SD corrected for duration of pregnancy and ethnic origin.
- •\- 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 \> \-2 SD corrected for duration of pregnancy and ethnic origin.
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.
Investigators
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