Long-term follow-up of infants with congenital CMV in New York State
Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
This study follows infants in New York who have congenital CMV to see how the infection affects their development, hearing, and vision as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Days to 1 Year |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT06226558 on ClinicalTrials.gov |
What this trial studies
This observational study tracks infants who test positive for congenital Cytomegalovirus (CMV) infection through the Newborn Screening program in New York State. The research aims to gather extensive data on the developmental, hearing, neurologic, and vision outcomes of these children over time. By assessing the range of symptoms and the impact of congenital CMV on affected families, the study seeks to enhance understanding of this condition and the effectiveness of interventions. Children will undergo regular developmental and hearing assessments to identify any complications early.
Who should consider this trial
Good fit: Ideal candidates include neonates born in New York State during the specified cCMV Newborn Screening Pilot Program who meet specific confirmatory testing criteria.
Not a fit: Patients who do not test positive for congenital CMV or do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and management of congenital CMV, ultimately enhancing outcomes for affected children.
How similar studies have performed: While this study builds on existing knowledge of congenital CMV, it aims to provide new insights and has the potential to enhance understanding of long-term outcomes, making it a valuable addition to the field.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stony Brook, New York
- Stony Brook Children's Hospital — Stony Brook, New York, United States (Recruiting)
Study contacts
- Study coordinator: Andrew Handel, MD
- Email: Andrew.handel@stonybrookmedicine.edu
- Phone: 631-444-7692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.