Long-Term Outcomes of Children With Congenital CMV in New York State
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.
Conditions:
🦠 Congenital CMV Infection 🦠 Sensorineural Hearing Loss
🗓️ Study Start (Actual) 1 February 2024
🗓️ Primary Completion (Estimated) 1 October 2024
✅ Study Completion (Estimated) 1 October 2026
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Stony Brook, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 0 Days to 1 Year (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 December 2023
  • First Submitted that Met QC Criteria 23 January 2024
  • First Posted 26 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024