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

Conditions

• Congenital CMV Infection
• Sensorineural Hearing Loss

Eligibility Criteria

Sex

ALL

Age

0 Days - 1 Year

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Feb 1, 2024

Status verified

May 2025

Primary completion

Oct 1, 2025

Completion

Oct 1, 2026

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Category 1: Confirmed cCMV infection identified by NYS newborn screen
  Infants who have both a positive cCMV NYS newborn screen AND are positive for cCMV on confirmatory testing
• Arm: Category 2: Confirmed cCMV infection NOT identified by NYS newborn screen
  Infants who have both a NEGATIVE cCMV NYS newborn screen AND are found to have cCMV on confirmatory testing
• Arm: Category 3: False-positive cCMV NYS newborn screen
  Infants who have both a positive cCMV NYS newborn screen AND are NEGATIVE for cCMV on confirmatory testing
• Arm: Category 4: Premature infants with confirmed CMV infection on late positive NBS
  Infants who are: (a) born prior to 37 weeks gestation AND (b) cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND (c) Have a positive cCMV confirmatory test obtained within 14 days of a positive NYS newborn screen

Primary Outcome Measure

Congenital CMV infection rate [ Time Frame: Study initiation to 1 year time point ]

Central Contacts

• Andrew Handel, MD
  631-444-7692
  [email protected]
• Sharon Nachman, MD
  631-444-7692
  [email protected]

Locations (1)

Find similar trials in Stony Brook, NY

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