Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT06226558

Conditions

Congenital CMV Infection

Sensorineural Hearing Loss

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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 ID

NCT06226558

Start date

Feb 1, 2024

Status verified date

May, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

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 and Locations

Central contacts

Andrew Handel, MD

631-444-7692Andrew.handel@stonybrookmedicine.edu

Sharon Nachman, MD

631-444-7692sharon.nachman@stonybrookmedicine.edu

Locations

Stony Brook Children's Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Andrew Handel, MD

631-444-7692Andrew.handel@stonybrookmedicine.edu

Principal Investigator:

Andrew Handel, MD

More Information

Sponsor

Stony Brook University

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Congenital CMV
  • cCMV
  • Congenital infection
  • Sensorineural hearing loss
  • SNHL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-05-13.