Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
Condition: Congenital Cytomegalovirus Infection; Sensorineural Hearing Loss
MeSH terms: Cytomegalovirus Infections; Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to investigate whether early treatment with oral valganciclovir
      of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can
      prevent progression of hearing loss.
    

Detailed description: 
      In the Netherlands all neonates are routinely screened for hearing during the first weeks
      after birth with the Otoacoustic Emissions (OAE) procedure. After the second refer an
      Automated Auditory Brainstem Response (AABR) is performed. The parents of all newborns, born
      at ≥ 37 weeks gestational age, that fail this AABR in the Netherlands (about 550 yearly) will
      be asked for consent for CMV-testing on the dried blood spots. Newborns diagnosed with
      congenital CMV and with confirmed SNHL (≥ 20 dB) are eligible for inclusion. After informed
      consent infants will be offered treatment before the age of 13 weeks (6 weeks valganciclovir
      32 mg/kg daily dose; oral solution). Parents may decide to participate in the trial in the
      control group (no antiviral treatment). Infants will be monitored for leucopenia and liver-
      and kidney function. Inclusion will continue for at least 1.5 years, or until at least 40
      infants have been included in the trial.

      At age 20 months hearing and child development are assessed in the follow-up. Hearing will be
      assessed with Brainstem Evoked Response Audiometry with the Vivosonic Integrity. Child
      development will be assessed with the Bayley Scales of Infant Development III (official Dutch
      translation) and parents will fill in the Dutch Child Development Inventory (NCDI) which will
      give more detailed information on communicative development of their child. The hearing
      assessment and developmental examination will be fulfilled during a home visit. Viral loads
      in blood and urine will be monitored during antiviral treatment as well as twice in the
      control group.

      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. The outcome may lead to implementation of congenital CMV
      testing in the neonatal hearing screening program or possibly into the newborn blood
      screening.
    

Intervention name(s): Valganciclovir
Intervention type(s): Drug
Intervention description(s): Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
Other intervention name(s): Valcyte; Valganciclovirhydrochloride
Intervention MeSH terms: Valganciclovir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cytomegalovirus; Congenital infection; Sensorineural hearing loss; Valganciclovir