Long-term follow-up of infants with congenital CMV in New York State

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.