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

Recruitingn/aAges 0 Days - 1 YearAllStony Brook University
NCT06226558 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 hearin

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Stony Brook Children's Hospital
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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