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
3 Weeks - 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