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After informed consent infants will be offered treatment before the age of 13 weeks (6 weeks valganciclovir 32 mg/kg daily dose; oral solution).
The hearing assessment and developmental examination will be fulfilled during a home visit. In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.Inclusion Criteria Treatment group and refusal control group - Infants with congenital CMV infection, and hearing loss (≥ 20 d B, in one or both ears). Epub 2008 Mar 6Vries JJ, Korver AM, Verkerk PH, Rusman L, Claas EC, Loeber JG, Kroes AC, Vossen AC. DECIBEL study: Congenital cytomegalovirus infection in young children with permanent bilateral hearing impairment in the Netherlands. - Age at time of inclusion is ≤ 12 weeks after birth. - Birth weight -2 SD corrected for duration of pregnancy and ethnic origin. Historical control group - Infants with congenital CMV infection, and hearing loss (≥ 20 d B, in one or both ears). Foulon I, Naessens A, Foulon W, Casteels A, Gordts F. Congenital cytomegalovirus infection in the Netherlands: birth prevalence and risk factors. Viral loads in blood and urine will be monitored during antiviral treatment as well as twice in the control group. In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
This study will provide information on the percentage of infants with a congenital CMV infection who fail the neonatal hearing screening .
The trial will show whether early treatment of congenital CMV infected children with hearing impairment prevents deterioration of hearing loss and to what extent. Fowler KB, Mc Collister FP, Dahle AJ, Boppana S, Britt WJ, Pass RF. Lanari M, Lazzarotto T, Venturi V, Papa I, Gabrielli L, Guerra B, Landini MP, Faldella G.