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Recruiting

NCT Number: NCT06226558

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.

Recruiting

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Key information

Conditions

Congenital CMV Infection Cytomegalovirus Infections DNA Virus Infections Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Herpesviridae Infections Infections Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms Virus Diseases

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stony Brook Children's Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Andrew Handel, MD

CONTACT

[email protected]

631-444-7692

Andrew Handel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Congenital CMV infection rate

    Time frame: Study initiation to 1 year time point

    To determine the rate of confirmed congenital CMV in a statewide cohort

Secondary outcomes

  1. cCMV neonatal sensorineural hearing loss

    Time frame: Through 4 weeks old

    Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing

  2. cCMV antiviral therapy utilization

    Time frame: 2 years

    Frequency of antiviral prescriptions

  3. cCMV acquired sensorineural hearing loss

    Time frame: 2 years

    Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing

  4. cCMV neurodevelopmental outcomes

    Time frame: 2 years

    Neurodevelopmental abnormalities as measured by Bayley Scales of Infant & Toddler Development-III.

    The Bayley-III includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales. Age-normalized scores are calculated for each domain, with a lower score indicating greater impairment.

  5. cCMV-related quality of life

    Time frame: 2 years

    Quality of life score as determined by the Pediatric Quality of Life Inventory Infant Scales (PedsQL).

    The PedsQL Infant Scales consist of parent-reported psychosocial health symptoms. A higher score on the PedsQL indicates more severe psychosocial health symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Handel, MD

CONTACT

[email protected]

631-444-7692

Sharon Nachman, MD

CONTACT

[email protected]

631-444-7692

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Frontier Science & Technology Research Foundation, Inc.

Registry information

Official study title

Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State

Acronym: PROACTIVE NYS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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