A multicentre clinical study on the diagnosis and treatment of sensorineural deafness caused by congenital cytomegalovirus infection

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044233

Enrollment

Unknown

Registered

2021-03-12

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital cytomegalovirus infection

Interventions

Mild control group:Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 3 weeks BID + 1 week QD

Mild test group:Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 6 weeks BID

Moderate to severe control group:Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 6 weeks BID

Moderate and severe test group:Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, course of treatment: 4 months BID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CMV pathogen testing is required for those who meet any of the following criteria (newborns 66umol/L)]; Or the central nervous system involvement; (6) Microcephaly (head circumference less than their peers 2 sd) and CMV; (7) Imaging of the central nervous system disease consistent anomaly in /severe ventricular expansion, calcification in the brain, abnormal ventricular echo, cortex and cerebellum malformation (except: expansion, single ventricle ependymal pseudocyst or lenticular striatum vascular lesions)]; (8) Retinitis; (9) CMV DNA was positive in cerebrospinal fluid.

Exclusion criteria

Exclusion criteria: (1) Patients with severe hearing impairment and positive detection of deafness gene; (2) ear canal malformation; (3) those with unstable vital signs; (4) gestational age 30 days; (8) children considered by the investigator to be inappropriate to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Blood routine;Liver and kidney function;Urinary CMV loads;CMV load of whole blood cells;Brain stem auditory evoked potential;Sound conductance tympanum diagram;Retinal screening;Griffiths Developmental Assessment Scale;	—

Countries

China

Contacts

Public ContactYinghu Chen

Children's Hospital Affiliated to Zhejiang University Medical College

chenyinghu@sina.com+86 0571-86670971

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026