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Evaluation of Long-term Efficacy of 4 to 6-month Course Antiviral Therapy for Neurodevelopmental Impairments Caused by Congenital Cytomegalovirus Infection: A Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial

Evaluation of Long-term Efficacy of 4 to 6-month Course Antiviral Therapy for Neurodevelopmental Impairments Caused by Congenital Cytomegalovirus Infection: A Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118780
Enrollment
Unknown
Registered
2026-02-10
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Congenital cytomegalovirus infection

Interventions

Intervention group:Intravenous ganciclovir (6 mg/kg, twice daily) or oral valganciclovir (16 mg/kg, twice daily) was administered for a treatment course of 4 months.
Control group:Patients received a 6-month course of anti-CMV therapy. The treatment regimen consisted of either intravenous ganciclovir (6 mg/kg, twice daily) or or

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1.Confirmed congenital cytomegalovirus (CMV) infection; 2.Infants with moderate to severe clinical manifestations; 3.Age at enrollment <= 30 days;

Exclusion criteria

Exclusion criteria: 1.Prematurity (<32 weeks of gestational age); 2.Birth weight <1.8 kg; 3.Absence of informed consent; 4.Abnormal hearing loss gene; 5.Coexisting genetic or metabolic diseases; 6.Occurrence of other intracranial infections during the disease course; 7.Incomplete data precluding evaluation.

Design outcomes

Primary

MeasureTime frame
Hepatic and renal function;Neurodevelopmental outcomes at 1 year of age;

Secondary

MeasureTime frame
Mild neurodevelopmental impairment at 1 year old;

Countries

China

Contacts

Public ContactYinghu Chen

Children's Hospital,Zhejiang University School of Medicine

chenyinghu@sina.com+86 571 8667 0974

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026