NL-OMON39229已完成3 期
The CONCERT study CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial - The Leiden CONCERT study
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
- •- 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.
排除标准
- •- 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).
研究者
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