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

Launched by STONY BROOK UNIVERSITY · Jan 23, 2024

Keywords

ClinConnect Summary

The PROACTIVE NYS study is looking at how congenital Cytomegalovirus (CMV) affects babies in New York State over the long term. Congenital CMV is a viral infection that babies can be born with, which may lead to hearing loss, developmental delays, and other health issues. This study will follow infants who test positive for CMV to understand the range of symptoms they may experience, from those with severe problems to those who show no signs at all. Researchers will gather important information about how CMV impacts children's development, hearing, vision, and overall well-being, as well as how it affects their families.

To participate in the study, babies must have tested positive for CMV through newborn screening in New York State between September 27, 2023, and October 1, 2024. Families who choose to join will need to complete regular check-ups that include developmental and hearing assessments. If any concerns arise during these assessments, children will be referred for further evaluation and treatment. Additionally, families will be asked to fill out surveys about their experiences with CMV, which will help researchers understand the condition better. This study is important for improving care and support for children with congenital CMV and their families.

Gender

ALL

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