NCT06226558

Long-Term Outcomes of Children With Congenital CMV in New York State

Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 0 Days – 1 Year
• Healthy volunteers: Not accepted

Summary

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms. In particular, our study will provide new information about many facets of congenital CMV, including: * Developmental, hearing, neurologic, and vision outcomes * The spectrum and timing of symptoms * The impact congenital CMV has on the baby and its family * How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications. Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment. Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.

Conditions

• Congenital CMV Infection
• Sensorineural Hearing Loss

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-01-26
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States