NL-OMON41461已完成3 期
CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group - CONCERT study 2.0
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •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.
- •- Parental signed informed consent.
排除标准
- •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.
研究者
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