Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

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Brief Title

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

Official Title

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

Brief 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 randomized before the age of 13 weeks to a treatment group (6 weeks
      valganciclovir 32 mg/kg daily dose; oral solution) or 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 25 infants in each treatment arm have been
      randomized.

      At 1 year follow-up hearing and child development are assessed. Hearing will be assessed with
      Brainstem Evoked Response Audiometry at an audiological center. Child development will be
      assessed during a home visit with the Bayley Scales of Infant Development III and parents
      will fill in the Dutch Child Development Inventory (NCDI) which will give more detailed
      information on communicative development of their child. 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 RCT 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Hearing assessment

Secondary Outcome

 Child development

Condition

Congenital Cytomegalovirus Infection

Intervention

Valganciclovir

Study Arms / Comparison Groups

 Valganciclovir
Description:  Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

2

Start Date

June 2012

Completion Date

October 2013

Primary Completion Date

October 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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.

          -  ≥ 37 weeks gestational age.

          -  Birth weight ≥ 2500 gram.

          -  Parental signed informed consent.

        Exclusion Criteria:

          -  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).

Gender

All

Ages

N/A - 12 Weeks

Accepts Healthy Volunteers

No

Contacts

Ann CT Vossen, Dr., ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT01655212

Organization ID

CMV-MM-1

Secondary IDs

2011-005378-44

Responsible Party

Sponsor-Investigator

Study Sponsor

Dr. Ann C.T.M. Vossen

Collaborators

 Stichting Nuts Ohra

Study Sponsor

Ann CT Vossen, Dr., Study Director, Leiden University Medical Center

Verification Date

June 2015