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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Stony Brook Children's Hospital
Stony Brook, New York, United States
RECRUITINGCongenital CMV infection rate
To determine the rate of confirmed congenital CMV in a statewide cohort
Time frame: Study initiation to 1 year time point
cCMV neonatal sensorineural hearing loss
Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Time frame: Through 4 weeks old
cCMV antiviral therapy utilization
Frequency of antiviral prescriptions
Time frame: 2 years
cCMV acquired sensorineural hearing loss
Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Time frame: 2 years
cCMV neurodevelopmental outcomes
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.
Time frame: 2 years
cCMV-related quality of life
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.
Time frame: 2 years
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