NCT06226558 Long-Term Outcomes of Children With Congenital CMV in New York State
| NCT ID | NCT06226558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stony Brook University |
| Condition | Congenital CMV Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-02-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Study participants meet criteria for one of the following four categories: * 1\. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive * 2\. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive * 3\. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test * 4\. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS Exclusion Criteria: * Neonate whose parents refuse participation in the long-term follow-up study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06226558 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 1 Year, studying Congenital CMV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226558 currently recruiting?
Yes, NCT06226558 is actively recruiting participants. Contact the research team at Andrew.handel@stonybrookmedicine.edu for enrollment information.
Where is the NCT06226558 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT06226558 clinical trial?
NCT06226558 is sponsored by Stony Brook University. The trial plans to enroll 1,000 participants.