Congenital CMV InfectionPROACTIVE NYSNCT06226558
Long-Term Outcomes of Children With Congenital CMV in New York State
An observational study of Congenital CMV Infection and Sensorineural Hearing Loss, run by Stony Brook University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Congenital CMV Infection, Sensorineural Hearing Loss
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Oct 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Neonate whose parents refuse participation in the long-term follow-up study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook Children's Hospital
Stony Brook, New York, 11794
Andrew Handel, MD, 631-444-7692, Andrew.handel@stonybrookmedicine.edu
Andrew Handel, MD
About this study
Official title: Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
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:
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- 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.
- Keywords
- Congenital CMV, cCMV, Congenital infection, Sensorineural hearing loss, SNHL
- Medical subject headings
- Cytomegalovirus Infections, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Category 1: Confirmed cCMV infection identified by NYS newborn screen | Infants who have both a positive cCMV NYS newborn screen AND are positive for cCMV on confirmatory testing | |
| Category 2: Confirmed cCMV infection NOT identified by NYS newborn screen | Infants who have both a NEGATIVE cCMV NYS newborn screen AND are found to have cCMV on confirmatory testing | |
| Category 3: False-positive cCMV NYS newborn screen | Infants who have both a positive cCMV NYS newborn screen AND are NEGATIVE for cCMV on confirmatory testing | |
| Category 4: Premature infants with confirmed CMV infection on late positive NBS | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Congenital CMV infection rate
To determine the rate of confirmed congenital CMV in a statewide cohort
Measured: Study initiation to 1 year time point
Secondary outcomes (5)
cCMV neonatal sensorineural hearing loss
Rate of neonatal sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Measured: Through 4 weeks old
cCMV antiviral therapy utilization
Frequency of antiviral prescriptions
Measured: 2 years
cCMV acquired sensorineural hearing loss
Rate of acquired sensorineural hearing decibel loss as determined by Auditory Brainstem Response testing
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital CMV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc.
- Responsible party
- Principal investigator, Andrew S Handel, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226558
- Sponsor's protocol ID
- 75N94021D00018-75N94023F00001
- Acronym
- PROACTIVE NYS
- Status last verified
- May 2025
- First submitted
- 19 Dec 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pesch MH, Saunders NA, Abdelnabi S. Cytomegalovirus Infection in Pregnancy: Prevention, Presentation, Management and Neonatal Outcomes. J Midwifery Womens Health. 2021 May;66(3):397-402. doi: 10.1111/jmwh.13228. Epub 2021 May 24.
PubMed 34031974Rawlinson WD, Boppana SB, Fowler KB, Kimberlin DW, Lazzarotto T, Alain S, Daly K, Doutre S, Gibson L, Giles ML, Greenlee J, Hamilton ST, Harrison GJ, Hui L, Jones CA, Palasanthiran P, Schleiss MR, Shand AW, van Zuylen WJ. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017 Jun;17(6):e177-e188. doi: 10.1016/S1473-3099(17)30143-3. Epub 2017 Mar 11.
PubMed 28291720Fowler KB, Boppana SB. Congenital cytomegalovirus infection. Semin Perinatol. 2018 Apr;42(3):149-154. doi: 10.1053/j.semperi.2018.02.002. Epub 2018 Mar 2.
PubMed 29503048