An observational study in Congenital CMV Infection and Sensorineural Hearing Loss, sponsored by Stony Brook University. Recruiting at 1 site in United States. Open to participants aged 0 Days to 1 Year. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Stony Brook University · Observational
Among 178 studies in Cytomegalovirus Infections with a site in United States — 15 open to participants now, 21 under way, 2 of them phase 3. Cytomegalovirus Infections · United States.
Among the 178 studies in Cytomegalovirus Infections with a site in United States, this one has the largest planned enrollment of the 25 observational ones that give a count, is one of 4 that started in 2024, is one of 25 observational ones, reaches primary completion later than 3 of the 20 other live ones, and was the 168th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
Browse Cytomegalovirus Infections studies →15 of the 178 studies in Cytomegalovirus Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Amivas Inc. · Sites in United States, Australia
Ages 18+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
University of Wisconsin, Madison · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: 0 Days to 1 Year · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
178 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 47 · Phase 3 25 · Phase 4 13
First in 1996; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 150 across 93 observational studies indexed under Cytomegalovirus Infections.
Median enrollment 61 across the 139 interventional studies, 153 across the 25 observational. Of the 151 that completed or were terminated, 44 (29%) have results posted.
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60 of 178 have an industry lead sponsor. The 10 most frequent:
Stony Brook University is the lead sponsor of 197 studies on the registry; 35 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Stony Brook University has 1 study filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
8 of the studies in Cytomegalovirus Infections with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06407232Phase 3University of Wisconsin, MadisonLetermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients | 2027-08 |
| NCT03354728City of Hope Medical CenterMulti-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant | 2026-12-11 |
| NCT06066957University of PennsylvaniaOpen Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients | 2026-12-15 |
| NCT03266640New York Medical CollegeVirus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) | 2026-12-31 |
| NCT05234723IRCCS Azienda Ospedaliero-Universitaria di BolognaGanciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients | 2027-02-28 |
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Among the 178 studies in Cytomegalovirus Infections with a site in United States, from their registry updates:
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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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infants who have both a positive cCMV NYS newborn screen AND are positive for cCMV on confirmatory testing
Infants who have both a NEGATIVE cCMV NYS newborn screen AND are found to have cCMV on confirmatory testing
Infants who have both a positive cCMV NYS newborn screen AND are NEGATIVE for cCMV on confirmatory testing
Infants who are: (a) born prior to 37 weeks gestation AND (b) cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND (c) Have a positive cCMV confirmatory test obtained within 14 days of a positive NYS newborn screen
Congenital 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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for Oct 2025, 20 months after the start.
Of 30 observational studies under Cytomegalovirus Infections, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 61. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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