Long-Term Outcomes of Children With Congenital CMV in New York State
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-1
SponsorStony Brook University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
1. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive
Disqualifiers
Neonate whose parents refuse participation in the long-term follow-up study
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 4 trial groupsGroup A: Category 1: Confirmed cCMV infection identified by NYS newborn screen
Group B: Category 2: Confirmed cCMV infection NOT identified by NYS newborn screen
Group C: Category 3: False-positive cCMV NYS newborn screen
Group D: Category 4: Premature infants with confirmed CMV infection on late positive NBS
Trial outcomes
Primary outcomes
1
Congenital CMV infection rate
To determine the rate of confirmed congenital CMV in a statewide cohort
Time frame
Study initiation to 1 year time pointSecondary outcomes
1
cCMV neonatal sensorineural hearing loss
Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Time frame
Through 4 weeks old2
cCMV antiviral therapy utilization
Frequency of antiviral prescriptions
Time frame
2 years3
cCMV acquired sensorineural hearing loss
Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Time frame
2 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stony Brook University
Lead sponsor
Frontier Science & Technology Research Foundation, Inc.
Collaborator
Source ClinicalTrials.gov