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

Recruiting

• Conditions: Congenital CMV Infection; Sensorineural Hearing Loss

• Registration Number: NCT06226558
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-26
• Study Start: 2024-02-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Congenital CMV infection rate	Study initiation to 1 year time point	To determine the rate of confirmed congenital CMV in a statewide cohort

Secondary Outcome Measures

Name	Time	Method
cCMV neonatal sensorineural hearing loss	Through 4 weeks old	Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
cCMV antiviral therapy utilization	2 years	Frequency of antiviral prescriptions
cCMV acquired sensorineural hearing loss	2 years	Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
cCMV-related quality of life	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.
cCMV neurodevelopmental outcomes	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.

Trial Locations

Locations (1)

Stony Brook Children's Hospital; 🇺🇸 Stony Brook, New York, United States