Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01655212
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
12 Weeks
Study:
NCT01655212
Study Brief:
Protocol Section:
NCT01655212