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
- Are there results?
- Not yet: the study is under way
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:
Read more
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
- ClinicalTrials.gov ID
- NCT06226558
- Acronym / sponsor ID
- PROACTIVE NYS / 75N94021D00018-75N94023F00001
- Keywords
- Congenital CMV, cCMV, Congenital infection, Sensorineural hearing loss, SNHL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc.
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Neonate whose parents refuse participation in the long-term follow-up study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Congenital CMV infection rate
Time frame: Study initiation to 1 year time point
To determine the rate of confirmed congenital CMV in a statewide cohort
5 secondary outcomes
cCMV neonatal sensorineural hearing loss
Time frame: Through 4 weeks old
cCMV antiviral therapy utilization
Time frame: 2 years
cCMV acquired sensorineural hearing loss
Time frame: 2 years
cCMV neurodevelopmental outcomes
Time frame: 2 years
cCMV-related quality of life
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 34031974Pesch 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.
- Background: PubMed 28291720Rawlinson 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.
- Background: PubMed 29503048Fowler 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.
- PROACTIVE NYS WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital CMV Infection and Sensorineural Hearing Loss, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Handel, MD (631-444-7692, Andrew.handel@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congenital CMV infection rate (time frame: Study initiation to 1 year time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06226558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.