Actively Recruiting
Long-Term Outcomes of Children With Congenital CMV in New York State
Led by Stony Brook University · Updated on 2025-05-13
1000
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
F
Frontier Science & Technology Research Foundation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Long-Term Outcomes of Children With Congenital CMV in New York State
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)
- cCMV evaluation provided by a designated NYS cCMV clinical referral site
- Family willing and able to complete all study procedures
- Participants meet criteria for one of the following categories: confirmed cCMV identified by NBS (positive newborn screen and confirmatory test), confirmed cCMV not identified by NBS (negative newborn screen but positive confirmatory test), false-positive cCMV screen (positive newborn screen but negative confirmatory test), or premature infants with confirmed CMV infection on late positive NBS (born before 37 weeks gestation, positive newborn screen prior to 44 weeks gestational age, and positive confirmatory test within 14 days of positive screen)
You will not qualify if you...
- Neonates whose parents refuse participation in the long-term follow-up study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stony Brook Children's Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
Research Team
A
Andrew Handel, MD
CONTACT
S
Sharon Nachman, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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