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.
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.
Brief Title
Long-Term Outcomes of Children With Congenital CMV in New York State
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
631-444-7692
Central Contact Email
Andrew.handel@stonybrookmedicine.edu
Central Contact Role
Contact
Central Contact Phone
631-444-7692
Central Contact Email
sharon.nachman@stonybrookmedicine.edu
Completion Date
Completion Date Type
Estimated
Conditions
Congenital CMV Infection
Sensorineural Hearing Loss
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Congenital CMV
cCMV
Congenital infection
Sensorineural hearing loss
SNHL
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
1 Year
Minimum Age
0 Days
NCT Id
NCT06226558
Org Class
Other
Org Full Name
Stony Brook University
Org Study Id
75N94021D00018-75N94023F00001
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
Primary Outcomes
Outcome Description
To determine the rate of confirmed congenital CMV in a statewide cohort
Outcome Measure
Congenital CMV infection rate
Outcome Time Frame
Study initiation to 1 year time point
Secondary Outcomes
Outcome Description
Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Outcome Time Frame
Through 4 weeks old
Outcome Measure
cCMV neonatal sensorineural hearing loss
Outcome Description
Frequency of antiviral prescriptions
Outcome Time Frame
2 years
Outcome Measure
cCMV antiviral therapy utilization
Outcome Description
Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Outcome Time Frame
2 years
Outcome Measure
cCMV acquired sensorineural hearing loss
Outcome Description
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.
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.
Outcome Time Frame
2 years
Outcome Measure
cCMV neurodevelopmental outcomes
Outcome Description
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.
The PedsQL Infant Scales consist of parent-reported psychosocial health symptoms. A higher score on the PedsQL indicates more severe psychosocial health symptoms.
Outcome Time Frame
2 years
Outcome Measure
cCMV-related quality of life
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
All infants referred by the New York State Newborn Screen Program to a clinical care referral site for a positive congenital CMV test will be approached for enrollment in PROACTIVE NYS. In addition, infants who are identified with cCMV as part of routine clinical care during the study period will be eligible to enroll in PROACTIVE NYS.
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
1
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Julia Piwoz
Investigator Email
jpiwoz@montefiore.org